FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2240008
·
Received September 8, 2011
Report
- Report Number
- 2017865-2011-05724
- Event Type
- Injury
- Date Received
- September 8, 2011
- Date of Event
- July 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
- MO
- 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 THE RIGHT VENTRICULAR LEAD EXHIBITED INTERMITTENT CAPTURE AT 2.0 V, 0.4 MS AND IMPEDANCE GREATER THAN 2000 OHMS IN THE BIPOLAR CONFIGURATION. THE LEAD WAS FRACTURED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |