FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 4072567
·
Received September 9, 2014
Report
- Report Number
- 2017865-2014-16507
- Event Type
- Injury
- Date Received
- September 9, 2014
- Date of Event
- June 30, 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 THAT THE OUTER AND INNER INSULATIONS WERE DAMAGED AT 27.2 CM FROM THE CONNECTOR PIN AS A RESULT OF CLAVICULAR CRUSH. ELECTRICAL TESTS CONFIRMED LOW LEAD IMPEDANCE AND SHORTING AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN CLINIC, THE RIGHT VENTRICULAR LEAD EXHIBITED LOW LEAD IMPEDANCE AND HIGH CAPTURE THRESHOLDS. UPON EXTRACTION, A LEAD FRACTURE DUE TO CLAVICULAR CRUSH WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554722 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |