FDA Adverse Event
Malfunction
Summary report: N
ACCENT SR
MDR report key: 3920692
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14298
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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 RIGHT VENTRICULAR AUTOCAPTURE SETUP, THE PULSE GENERATOR EXHIBITED LOSS OF CAPTURE. AUTOCAPTURE WAS DISABLED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396892 | ACCENT SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |