FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2014154
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01477
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- January 20, 2011
- 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 Location
- OR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND AN ELECTRICAL SHORT CIRCUIT DUE TO DAMAGED PROXIMAL AND DISTAL INSULATIONS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE IN THE BIPOLAR CONFIGURATION. NO CAPTURE AND SENSING WAS ALSO NOTED. THE LEAD WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |