FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2083869
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-03057
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- May 17, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 8.7 CM TO 9.0 CM FROM THE CONNECTOR PIN AND THE PROXIMAL COIL WAS EXPOSED AT THE SAME AREA WHICH WOULD ACCOUNT FOR THE REPORTED NOISE ANOMALY. THE LOCATION OF THE ABRASION WAS CONSISTENT WITH THAT OF FRICTION TO THE DEVICE CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WILL BE MONITORED.
Description of Event or Problem · 1
AN INSULATION ANOMALY WAS ALSO REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |