FDA Adverse Event
Malfunction
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 1955296
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00546
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- October 21, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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 T-WAVE OVERSENSING WAS NOTED DURING A VENTRICULAR CAPTURE TEST. THE PACING LEAD IMPEDANCE HAD DECREASED AND THE CAPTURE HAD INCREASED BUT THE SENSING WAS STABLE. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | SP02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |