FDA Adverse Event
Malfunction
Summary report: N
ENDURITY DR
MDR report key: 3920732
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14343
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 27, 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE DEVICE WAS WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE PULSE GENERATOR HEADER WAS UNABLE TO ACCEPT THE VENTRICULAR AND ATRIAL LEAD. DUE TO RESISTANCE, THE PHYSICIAN DECIDED NOT TO IMPLANT THE DEVICE. A NEW DEVICE WAS IMPLANTED WITHOUT DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396418 | ENDURITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2160 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |