FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 5141502
·
Received October 9, 2015
Report
- Report Number
- 2017865-2015-29355
- Event Type
- Injury
- Date Received
- October 9, 2015
- Date of Event
- July 29, 2015
- Report Date
- August 14, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE AND AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED DURING A DEVICE CHANGEOUT PROCEDURE. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671414 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1888TC/52 | 0002130813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |