FDA Adverse Event
Malfunction
Summary report: N
MEMBRANE EX
MDR report key: 2983910
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01395
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 16, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P800041
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT, THE LEAD INSULATION EXHIBITED AN ANOMALY AND WAS FRACTURED. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88597 | MEMBRANE EX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1474T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |