FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL SR
MDR report key: 3925706
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15217
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- May 3, 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
- IN
- 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, THE LEAD WAS UNABLE TO BE SECURED INTO THE HEADER OF THE PULSE GENERATOR. AFTER SEVERAL ATTEMPTS, THE PULSE GENERATOR BECAME DAMAGED. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405259 | ZEPHYR XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | 5626 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |