FDA Adverse Event
Malfunction
Summary report: N
ENDURITY DR
MDR report key: 4231219
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18043
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- September 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 IMPLANT OF THE PULSE GENERATOR, THE PHYSICIAN HAD DIFFICULTY INSERTING A LEAD INTO THE ATRIAL HEADER PORT OF THE DEVICE. LUBRICATING OIL WAS USED AND THE LEAD WAS FULLY INSERTED. THE DEVICE WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715286 | ENDURITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2160 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | PM2160, 2957397 |