FDA Adverse Event
Injury
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 4173977
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16673
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
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 ER. INTERROGATION SHOWED PATIENT RECEIVED TWO SHOCKS DUE TO LEAD NOISE. ABORTED SHOCKS FROM NOISE DETECTION WERE ALSO OBSERVED. LEAD FRACTURE WAS NOTED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655460 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | SP01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |