FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 3923384
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14655
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND A PARTIAL LEAD WAS RECEIVED. INSULATION DEGRADATION WAS NOTED AT 4.6 CM FROM THE CONNECTOR PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE UPGRADE PROCEDURE, AN INSULATION ANOMALY NEAR THE CONNECTOR PIN WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401484 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |