FDA Adverse Event
Malfunction
Summary report: N
SUSTAIN XL DR
MDR report key: 3920713
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14303
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 24, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED STATED THAT ANOTHER OCCURRENCE OF PREMATURE ELECTIVE REPLACEMENT INDICATOR OCCURRED AT AN UNKNOWN DATE FOLLOW UP. NO INTERVENTION OR PATIENT SYMPTOMS WERE REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR. THE PATIENT WAS ASYMPTOMATIC. THE ELECTIVE REPLACEMENT INDICATOR WAS CLEARED THROUGH DEVICE REPROGRAMMING ON (B)(4) 2014. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396345 | SUSTAIN XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2136 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |