FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2905386
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00709
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- November 27, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT ONLY THE PROXIMAL PART OF THE LEAD MEASURING 17.5 CM WAS RETURNED. ANALYSIS WAS NORMAL FOR THE PART THAT WAS RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHEST PALPITATION. THE LEAD EXHIBITED DECREASED IMPEDANCE. A CHEST X-RAY REVEALED THAT THE LEAD INSULATION WAS BROKEN. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12742 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |