FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 4231391
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18188
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 10, 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
- TN, 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 POST IMPLANT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND UNDERSENSING. THE LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714618 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |