FDA Adverse Event
Injury
Summary report: N
TVL LEAD, SUPERIOR VENA CAVA
MDR report key: 2242964
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06610
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 9, 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. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND. WITHOUT THE RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD VF AND HAD TO BE RESUSCITATED AT THE HOSPITAL. AFTERWARD, DEVICE INTERROGATION REVEALED POSSIBLE OUTPUT CIRCUITRY DAMAGE. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL LEAD, SUPERIOR VENA CAVA | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | SV02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |