FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2240321
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05548
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- June 27, 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXP DATE SHOULD HAVE BEEN 31-MAR-2014 RATHER THAN 31-MAY-2012. MFR DATE SHOULD HAVE BEEN 25-MAR-2011 RATHER THAN 01-MAY-2009. (B)(4). FINAL ANALYSIS FOUND THAT BOTH THE PROXIMAL AND DISTAL INSULATIONS WERE DAMAGED AT 26.7 CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH. THE DAMAGED DISTAL INSULATION RESULTED IN A SHORT BETWEEN THE COILS. THIS WOULD CAUSE THE REPORTED NOISE ANOMALY.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED 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/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | (B)(4) |