FDA Adverse Event
Malfunction
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 1955038
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00542
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- October 4, 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
- NJ
- 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 PATIENT PRESENTED TO THE CLINIC DUE TO NOISE ON THE LEAD. THE NOISE WAS REPRODUCIBLE WITH ISOMETRICS. THE PATIENT DID NOT RECEIVE INAPPROPRIATE THERAPY. THE PHYSICIAN OPTED TO MONITOR THE LEAD AND PATIENT.
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 | SP01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR |