FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 2240430
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05537
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- June 8, 2011
- 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 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
IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT, THE LEAD EXHIBITED A HIGH THRESHOLD OF 4.5 V, 1.0 MS AND A HIGH IMPEDANCE OF 3321 OHMS IN THE BIPOLAR CONFIGURATION. THE LEAD WAS CAPPED.
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 | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |