FDA Adverse Event
Malfunction
Summary report: N
SUSTAIN XL DR
MDR report key: 3920749
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14332
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 23, 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 Occupation
- OTHER
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 THE PATIENT HAD UNDERGONE RADIATION THERAPY. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED A MESSAGE INDICATING A SOFTWARE ERROR HAD OCCURRED. STORED DEVICE IDENTIFICATION INFORMATION HAD BEEN DELETED AS WELL. THE PULSE GENERATOR WAS SUCCESSFULLY REPROGRAMMED AND NORMAL DEVICE FUNCTION RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396923 | SUSTAIN XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2136 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |