FDA Adverse Event
Injury
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 2242963
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06608
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 27, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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 HV LEAD IMPEDANCE WAS HIGH IN THE SVC TO CAN CONFIGURATION. DURING AN LV LEAD IMPLANT PROCEDURE, THE LEAD WAS REMOVED FROM THE ICD AND RESEATED. THE IMPEDANCE WAS NOW NORMAL, BUT THE SENSING VALUES HAD DECREASED. PATIENT WILL BE MONITORED.
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 | 64 YR | Required Intervention |