FDA Adverse Event
Malfunction
Summary report: N
ENDURITY DR
MDR report key: 3920667
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14262
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 28, 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
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEAD(S) INTO THE PULSE GENERATORS HEADER AND THE LEAD INSERTION FORCE USED TO INSERT THE LEAD WAS OUT OF SPECIFICATION FOR THE PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR CONNECTOR WOULD NOT ACCEPT THE ATRIAL LEAD. WHEN THE LEAD WAS INSERTED AND TIGHTENED DOWN, NOISE WAS SEEN ON THE LEAD. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396149 | ENDURITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2160 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |