FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2240458
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05863
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 15, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE DISTAL INSULATION WAS DAMAGED DUE TO AN OVERTORQUED DISTAL COIL, CREATING A SHORT IN BETWEEN THE PROXIMAL AND DISTAL COILS, RESULTING IN LOW LEAD IMPEDANCE.
Description of Event or Problem · 1
A PRODUCT PERFORMANCE ISSUE WAS REPORTED. THE LEAD WAS RE- MOVED AND REPLACED.
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 | 79 YR | Required Intervention | 1788T/58 (B)(4) , 1788T/52 (B)(4) |