FDA Adverse Event
Injury
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 2083851
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-03793
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- January 24, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO RE-EVALUATION OF EVENT.
Additional Manufacturer Narrative · 1
PLEASE RETRACT THIS MANUFACTURER (MFR) REPORT NUMBER 2017865-2011-03793 AS THIS DEVICE WAS PREVIOUSLY REPORTED ON TIME ON (B)(6) 2011 UNDER MFR REPORT NUMBER 2017865-2011-02380.
Description of Event or Problem · 1
DURING THE ICD REPLACEMENT, THE PHYSICIAN OBSERVED THE LEAD WAS SLIGHTLY DAMAGED. LOW VENTRICULAR SENSING WAS NOTED. THE LEAD WAS DISCARDED AT EXPLANT. THE PATIENT WAS IN GOOD CONDITION AT THE END OF THE PROCEDURE.
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 | Required Intervention |