FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3924065
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14986
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 23, 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD PERFORATED THE RIGHT VENTRICULAR APEX. THE LEAD EXHIBITED INAPPROPRIATE SENSING AND INCREASED THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION AND NO OTHER COMPLICATIONS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399353 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |