FDA Adverse Event
Injury
Summary report: N
FORTIFY ASSURA VR, DF-4 CONNECTOR
MDR report key: 4760314
·
Received May 8, 2015
Report
- Report Number
- 2938836-2015-04720
- Event Type
- Injury
- Date Received
- May 8, 2015
- Date of Event
- March 20, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED VIA REMOTE TRANSMISSION. SUDDEN DECREASE IN SENSING AND INCREASE IN PACING LEAD IMPEDANCE WERE ALSO OBSERVED. DURING REVISION IT WAS FOUND THAT THE SET SCREW WAS LOOSE. AFTER TIGHTENING THE SET SCREW, THE ISSUE WAS RESOLVED. PATIENT WAS FINE POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302495 | 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 | 79 YR | Required Intervention |