HC Deb 05 November 1993 vol 231 cc532-3W
Mrs. Bridget Prentice

To ask the Secretary of State for Health who was responsible for warning hospitals of faults in pacemaker models 1010T, 1050T and Prototype 93 manufactured by Siemens.

Mr. Sackville

The manufacturer has a responsibility to advise users and purchasers when faults in their products become apparent. My right hon. Friend the Secretary of State, via the medical devices directorate, issues safety warnings in circumstances where there is a risk to patient safety from device faults.

Mrs. Bridget Prentice

To ask the Secretary of State for Health what monitoring has been done of the recall of patients fitted with pacemaker models 1010T, 1050T and Prototype 93.

Mr. Sackville

Following the issue of safety warnings it is for the clinician concerned to judge what action should be taken in respect of each patient.

Mrs. Bridget Prentice

To ask the Secretary of State for Health when hospitals were warned of a fault in pacemaker models 1010T, 1050T and Prototype 93 manufactured by Siemens.

Mr. Sackville

Hospitals were warned of a fault in pacemaker lead models 1010T, 1050T and Prototype T93 by a medical advisory issued by Siemens on 4 February 1993, copies of which will be placed in the Library.

Mrs. Bridget Prentice

To ask the Secretary of State for Health which hospitals were warned of faults in pacemaker models 1010T, 1050T and Prototype 93.

Mr. Sackville

The Department of Health issued a safety warning "Pacemaker Technical Note No. 48" concerning the faults in Siemens pacemaker lead models 1010T, 1050T and Prototype T93 to all hospitals carrying out pacing and pacing follow-up in the United Kingdom. Copies of the safety warning are available in the Library.

Mrs. Bridget Prentice

To ask the Secretary of State for Health how many patients in(a) Lewisham, (b) London and (c) nationwide have been recalled as a result of the fault in pacemaker models 1010T, 1050T and Prototype 93.

Mr. Sackville

In February 1993, the Department of Health issued advice to all United Kingdom pacing and follow-up centres that all affected devices should be evaluated as soon as possible and at least within six months. Details of the number of patients seen as a result of this advice is not available centrally. Copies of the advice are available in the Library.