FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2905287
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00641
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- November 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 Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4): DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO SYNCOPE. UPON INTERROGATION, NOISE ALERTS WERE NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD EXHIBITED IMPEDANCE LESS THAN 100 OHMS. A FLUOROSCOPIC IMAGE EXHIBITED A CUT ON THE OUTER INSULATION. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12295 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |