FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 4231437
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18201
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- August 18, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 THE ATRIAL LEAD HAD PERFORATED THE PATIENT WHICH WAS CONFIRMED VIA ECHOCARDIOGRAPHY. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENTS CONDITION WAS GOOD AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713493 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |