FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA VR
MDR report key: 4220946
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17463
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- August 11, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF FAILURE TO DELIVER HIGH VOLTAGE THERAPY WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE STORED ELECTROGRAMS NOTED THAT THE DEVICE DETECTED EXCESSIVE CURRENT DURING DELIVERY OF SEVERAL SHOCK AFTER INDUCTION. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE FAILURE TO DELIVER HIGH VOLTAGE THERAPY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN INDUCTION TEST AFTER THE DEVICE WAS IMPLANTED, THE DEVICE CHARGED, BUT NO THERAPY WAS DELIVERED. THE DEVICE WAS NOT USED AND WAS REPLACED. PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703470 | FORTIFY ASSURA VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1357-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |