FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1011246
·
Received January 25, 2008
Report
- Report Number
- 1011246
- Event Type
- Malfunction
- Date Received
- January 25, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 25, 2008
- Manufacturer
- MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
LEADS DID NOT APPEAR TO FUNCTION PROPERLY WHEN THEY WERE IMPLANTED. THERE WAS ABNORMALLY HIGH LEAD IMPEDANCE. THIS WAS OF CONCERN TO THE PHYSICIAN BECAUSE THE SAME THING HAPPENED A COUPLE OF WEEKS AGO WHEN IMPLANTING THE SAME TYPE OF LEADS (I.E. SAME CATALOG #, ETC.) THOSE LEADS WERE NOT SAVED, AS IT WAS THE FIRST TIME AN EVENT LIKE THIS HAS HAPPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | LEAD, PACEMAKER | DTB | MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT | 5076 | * | |
| 2 | * | LEAD, PACEMAKER | DTB | MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT | 5076 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | NO OTHER THERAPIES| NO OTHER THERAPIES |