FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 3924167
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15088
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND AN INSULATION ABRASION AT 11.9 CM TO 12.1CM FROM THE CONNECTOR PIN WHICH EXPOSED THE OUTER COIL. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. THIS LIKELY CONTRIBUTED TO THE REPORTED ELECTRICAL ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE, OVERSENSING, AND AN INSULATION ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399582 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |