FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3925754
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15235
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- May 19, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND AN INSULATION ABRASION EXPOSING THE OUTER COIL AT 14.7 CM TO 15.1 CM FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. THIS LIKELY CONTRIBUTED TO THE REPORTED ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404395 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | (B)(4) |