FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 6111627
·
Received November 17, 2016
Report
- Report Number
- 2938836-2016-14407
- Event Type
- Injury
- Date Received
- November 17, 2016
- Date of Event
- October 18, 2016
- Report Date
- October 18, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY. UPON INTERROGATION, IT WAS NOTED THAT THE RV LEAD WAS SENSING P-WAVES AND R-WAVES AND RESULTED IN INAPPROPRIATE THERAPY. DIAGNOSTIC IMAGING REVEALED THAT THE LEADS HAD DISLODGED CAUSED BY TWIDDLER¿S SYNDROME. THE FOLLOWING DAY THE RV LEAD WAS EXTRACTED AND REPLACED, AND THE ATRIAL LEAD WAS REUSED. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761322 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 2088TC/52 | A000023181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | (B)(4) |