FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 4231378
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18161
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 3, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND INSULATION ABRASION AT 11.1 CM TO 11.7 CM FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. THIS LIKELY CONTRIBUTED TO THE REPORTED COMPLAINT OF NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715043 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |