FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3314742
·
Received August 28, 2013
Report
- Report Number
- 2938836-2013-05133
- Event Type
- Malfunction
- Date Received
- August 28, 2013
- Date of Event
- July 17, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 DURING EXPLANT FOR A NORMAL ERI, WHEN THE CHRONIC LEAD WAS CONNECTED TO THE NEW DEVICE AND DFT TESTING WAS PERFORMED, THE THERAPY DID NOT RESCUE THE PATIENT. THE PATIENT WAS EXTERNALLY RESCUED. AN ALERT FOR LOW HV LEAD IMPEDANCE WAS OBSERVED. ETP WAS ENTERED TO CLEAR THE HV LEAD MESSAGE. THE LEAD WAS CAPPED AND REPLACED.
Description of Event or Problem · 1
FURTHER INFORMATION NOTES EXTERNALIZED CONDUCTORS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422658 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |