HC Deb 07 March 1994 vol 239 cc81-2W
Mrs. Bridget Prentice

To ask the Secretary of State for Health how many patients with(a) Siemens and (b) Medtronic pacing leads which have been subject to warnings have had the leads replaced or inactivated.

Information based upon data returned to the national pacemaker database
Pacemaker lead 1987 1988 1989 1990 1991 1992 1993 1994
Number of pacemaker lead implants
Medtronic 4004 0 0 18 60 32 3 0 0
Medtronic 4004M 0 2 19 7 192 196 30 0
Medtronic 4082 0 0 0 142 619 515 1 0
Siemens 1010T 84 332 591 989 679 19 7 0
Siemens 1050T 3 2 56 745 1,235 13 0 0
Siemens T93 0 0 0 0 0 0 0 0
Number of deaths of patients treated with pacemaker lead
Medtronic 4004 0 0 7 11 5 0 0 0
Medtronic 4004M 0 0 0 5 14 21 1 0
Medtronic 4082 0 0 0 12 35 16 0 0
Siemens 1010T 7 34 62 74 68 0 0 0
Siemens 1050T 0 0 0 11 68 64 1 0
Siemens T93 0 0 0 0 0 0 0 0

Note: None of the deaths given above for either the Siemens or Medtronic pacemaker leads was lead-related. (Information based upon data returned to the National Pacemaker Database).

Mrs. Bridget Prentice

To ask the Secretary of State for Health what recommendations her Department has made to pacing centres and follow-up centres about the incidence of failures in polyurethane leads.

Mr. Sackville

Advice issued is contained in pacemaker technical notes Nos. 48, and 49, copies of which are available in the Library.

Mrs. Bridget Prentice

To ask the Secretary of State for Health what guidance has been given regarding the purchase of polyurethane leads by(a) her Department and (b) the medical devices directorate.

Mr. Sackville

The medical devices directorate, a division of the Department of Health, gives no specific advice on the purchase of polyurethane leads. However, purchasers are strongly recommended to buy medical devices only from companies registered under the Department's manufacturer registration scheme.

Mr. Sackville

According to information sent to the national pacemaker database, 224 Siemens pacing leads, and 39 Medtronic pacing leads subject to warnings, have been replaced or inactivated in the United Kingdom.

Mr. Bridget Prentice

To ask the Secretary of State for Health how many patients have been implanted with(a) Sorin 580T silicone pacemaker leads, (b) Talectronics 330258158 pacemaker leads, (c) Talectronics 033301 pacemaker leads, (d) Medtronic 4004 pacing leads, (e) Medtronic 4004M pacing leads, (f) Medtronic 4082 pacing leads, (g) Siemens 1010T pacing leads, (h) Siemens 1050T pacing leads and (i) Siemens prototype T93 since 1987; and how many have died in each category, in each year since 1987.

Mr. Sackville

There is no 580T pacemaker lead made by Sorin Biomedica, and no records exist of pacemaker leads with the model numbers 330258158 and 033301.

Information requested for the Medtronic and Siemens pacemaker leads, based upon data returned to the national pacemaker database, is shown in the table.

Mrs. Bridget Prentice

To ask the Secretary of State for Health what review her Department has conducted of the use of polyurethane in pacing leads; and if she will make a statement.

Mr. Sackville

No formal review has been conducted. The Department is continually up-dated by the national pacemaker database which analyses statistics on the use of all types of implantable pacemaker leads.