FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 4231392
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18189
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- August 1, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING POST-OP FOLLOW-UP, THE ATRIAL LEAD EXHIBITED SENSING ANOMALY. CHEST X-RAY REVEALED THE LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT WAS DOING WELL POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715105 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |