FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1050410
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01396
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- September 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMAP960013
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT ONE OF THE WIRES OF THE DISTAL COIL WAS FRACTURED AT 22.4 CM FROM THE CONNECTOR PIN. THE DISTAL INSULATION WAS ABRADED AT THE SAME LOCATION. THE PROXIMAL INSULATION WAS ABRADED AT 13 CM FROM THE CONNECTOR PIN.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
A POSSIBLE FRACTURED WAS NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE. ATRIAL LEAD IMPEDANCE WAS IN THE MID TO UPPER 200'S RANGE SINCE MAY 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388T/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |