FDA Adverse Event
Injury
Summary report: N
TENDRIL SDK
MDR report key: 1337813
·
Received March 10, 2009
Report
- Report Number
- 2017865-2009-00696
- Event Type
- Injury
- Date Received
- March 10, 2009
- Date of Event
- January 18, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE LEAD EXHIBITED HIGH IMPEDANCE, IT WAS CAPPED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED A LOW BIPOLAR IMPEDANCE OF 248 OHMS. ON THE LEAD IMPEDANCE TREND IT HAD DIPPED BELOW 200 OHMS IN 2008. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDK | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |