FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2983754
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01514
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 20, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE HELIX CAUSED THE DISTAL COIL TO BECOME OVER TORQUE, RESULTING IN THAT THE DISTAL COIL COLLAPSED AND DAMAGED THE DISTAL INSULATION AND CONSEQUENTLY ALSO SHORT CIRCUITED THE LEAD COILS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCE LESS THAN 200 OHMS AND AN INSULATION ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87923 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |