FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3924056
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14979
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 14, 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
- 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 PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND UNDERSENSING DUE TO SUSPECTED LEAD DISLODGEMENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(4) 2014. THE PATIENT WAS FINE DURING AND POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400654 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |