FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA VR, DF-4 CONNECTOR
MDR report key: 3910990
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-13011
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- April 22, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF HIGH DFTS WAS NOT VERIFIED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE DID NOT CONVERT THE PATIENT DURING DFT TESTING. THE LEAD AND DEVICE WERE REPLACED. DFTS WERE SUCCESSFUL WITH THE NEW SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385870 | FORTIFY ASSURA VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1357-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | (B)(4) |