§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health from what sources her Department arrives at a figure for deaths of patients implanted with pacemaker lead models 1010T, 1050T and Prototype 93.
§ Mr. SackvilleData relating to the number of patient deaths for individuals implanted with the pacemaker leads are obtained from the national pacemaker database located at the Royal Brompton National heart and lung hospital, London.
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§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health how implant centres and follow-up centres are informed that pacemaker lead model 1010T includes prototype 93.
§ Mr. SackvilleCentres were informed of a fault in the Siemens pacemaker lead model 1010T by the Department of Health pacemaker technical note No. 48, which included the Siemens medical advisory as an attachment. Paragraph 5 of the attachment identified all associated leads and their prototypes, including the T93 prototype. Copies of the technical note are available in the Library.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health how many people have been implanted with pacemaker lead models 1010T, 1050T and prototype 93.
§ Mr. SackvilleAccording to the National Pacemaker Registry a total of 4,675 pacemaker leads of models 1010T, 1050T and prototype T93 have been implanted in patients within the United Kingdom.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health what assessment he has made of the adequacy of the identification of pacemaker lead prototype 93 in Pacemaker note No. 48.
§ Mr. SackvilleAttention was drawn to the prototype T93 in two separate communications to all relevant clinicians. The details were contained in the manufacturer's advisory notice which was attached to the Department of Health technical note No. 48, and which had been issued previously by the company. Copies of the technical note are available in the Library.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health what recent guidance her Department has issued in respect of the identification of those deaths in patients fitted with pacemakers which may be due to faulty pacemaker leads.
§ Mr. SackvilleNo guidance has been issued by the Department of Health. Identification of the cause of death is made by the relevant medical practitioner.