FDA Adverse Event
Injury
Summary report: N
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4153708
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16321
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- August 20, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS DISLODGED AND PERFORATED THE VENTRICLE WHEN THE PATIENT FELL. THE LEAD WAS CAPPED. THE PATIENTS CONDITION WAS GOOD AFTER THE EVENT.
Description of Event or Problem · 1
NEW INFORMATION NOTES THAT THE LEAD WAS EXPLANTED AND NOT CAPPED AS PREVIOUSLY NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631754 | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | LDA230Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |