FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2983916
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01488
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 8, 2013
- 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 Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND INSULATION DEGRADATION AT 4.4 CM AND AT 5.0 CM TO 5.2 CM FROM THE CONNECTOR PIN. THIS COULD LIKELY CAUSE A SHORT BETWEEN THE PROXIMAL COIL AND THE DEVICE CAN RESULTING IN THE COMPLAINT AS REPORTED FROM THE FIELD.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED INTERMITTENT CAPTURE, HIGH THRESHOLD, UNDER SENSING AND AN INSULATION AMOMALY. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88599 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1882TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | (B)(4) |