FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1896535
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05021
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 22.5 CM TO 23.1 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH ANOTHER DEVICE, WHICH COULD CAUSE THE NOISE PROBLEM. THE PROXIMAL INSULATION WAS ALSO CUT AT 7.2 CM AND AT 19.2 CM FROM THE CONNECTOR PIN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
CUSTOMER DESCRIBED PATIENT AS ELDERLY, IN EXTREMIS. MEPILEX BORDER SACRUM APPLIED PROPHYLACTICALLY TO REDUCE CHANCE OF PRESSURE ULCER. SUSPECTED DEEP TISSUE INJURY DEVELOPED UNDER DRESSING. PATIENT EXPIRED ONE DAY LATER ((B)(6) 2010).
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE ECGM'S. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |