FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2083738
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-02890
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- February 11, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 18.5 CM FROM THE CONNECTOR PIN. ABRASIONS ARE INDICATIVE OF EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INSULATION EXHIBITED AN ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 1888TC/58, (B)(4) |