FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA DR CRT-D
MDR report key: 4130750
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16133
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- September 23, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLARIFICATION OF EVENT: NEW INFORMATION NOTES THAT A MERLIN.NET ALERT TRANSMISSION WAS NOT RECEIVED FOR THE BACK-UP VVI. THE PATIENT PRESENTED AFTER FEELING HIS HEART POUNDING AND HAVING HICCUPS THAT AWOKE HIM. THE DEVICE WAS FOUND IN BACK-UP VVI DURING MANUAL INTERROGATION. THE PATIENT STATES HE DID NOT FEEL THE PATIENT NOTIFIER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION REVEALED THAT THE DEVICE WAS IN BACK-UP VVI MODE. THE ASYMPTOMATIC PATIENT WAS BROUGHT INTO THE CLINIC FOR DEVICE INTERROGATION. THE DEVICE WAS SUCCESSFULLY RESTORED WITH A DOWNLOAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607994 | QUADRA ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3365-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |