To ask the Secretary of State for Health if the Medical Devices Agency has a record of patients with pacemakers in England and Wales; and if he will make a statement. [82398]
Pacemaker patient records are not held by the Medical Devices Agency. Patients implanted with pacemakers are registered with the National Pacemaker Database (NPD), using data supplied by implanting hospitals on a voluntary basis.
In a survey conducted by the NPD in 1997, it was estimated that in 1996 approximately 94 per cent. of all pacemaker implants were recorded on the database.
To ask the Secretary of State for Health how many Siemens Sensolog 2033T pacemakers have been supplied by the NHS for use in England and Wales. [82402]
The Department does not hold this information. However, the National Pacemaker Database has 377 United Kingdom patients (including implants under the National Health Service and in private practice) registered as having received a Sensolog 2033 pacemaker implant, 268 of which are for the 2033T. The suffix T refers only to the configuration of the pacemaker connector into which the pacemaker lead is attached.
To ask the Secretary of State for Health what plans he has to review the regulations regarding the recording of patients with pacemakers. [82397]
We have no plans to review current arrangements for the recording of patients with pacemakers. The maintenance of patient records is a matter of clinical practice and is not subject to regulation. The voluntary recording of pacemaker implants by clinicians with the National Pacemaker Database is endorsed by the British Pacing and Electrophysiology Group, the professional body for clinicians practising cardiac pacing.
To ask the Secretary of State for Health if he will list (a) the companies which manufacture pacemakers supplied by the NHS and which are used by patients in England and Wales, (b) the type of pacemaker supplied by the NHS and (c) the number of patients who use each type. [82403]
Information recorded by the National Pacemaker Database indicates that the following companies have, at some time, supplied pacemakers to United Kingdom pacing centres: Medtronic, Pacesetter (St. Jude Medical), Vitatron, CPI Guidant, Biotronik, Siemens, Sultzer Intermedics, Telectronics, Sorin Biomedica, ELA, Cordis, Biotec, Medico, Implantronik, APC Medical, Paladin, Precimed, Medcor, LEM, American Optical, Coratomic, Arco, Cardiac Control Systems, Lucas, Corporel. A number of these companies no longer supply pacemakers today.Information relating to the types and numbers of pacemakers supplied by individual manufacturers is not published because of commercial sensitivity.
To ask the Secretary of State for Health when the Siemens Sensolog 2033T pacemaker was withdrawn from sale; and when the Medical Devices Agency was informed of its withdrawal. [82400]
The manufacturer last sold this pacemaker in the United Kingdom in 1994, when it was superseded by a newer model. The Medical Devices Agency was not informed as the discontinuation was for commercial reasons and not in response to any known safety concerns.
To ask the Secretary of State for Health what is the procedure for alerting patients who have pacemakers which are withdrawn from supply because of faults in manufacture. [82399]
Pacemaker manufacturers are primarily responsible for issuing information to hospitals if a fault associated with any of their products is identified. If the Medical Devices Agency determines that a significant risk remains to the safety of pacemaker patients, it issues advice to clinicians at all United Kingdom pacing clinics to assist them in patient management. Clinicians are responsible for providing appropriate advice to their patients.
To ask the Secretary of State for Health how many Siemens Sensolog 2033T pacemakers have been referred to the Medical Devices Agency as having faults. [82401]
Only one United Kingdom adverse incident involving the Sensolog 2033 pacemaker model (including the 2033T) has been reported to the Medical Devices Agency.