FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 4072888
·
Received January 10, 2014
Report
- Report Number
- 2017865-2014-01375
- Event Type
- Malfunction
- Date Received
- January 10, 2014
- Date of Event
- June 22, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OPERATING ROOM TO HAVE THE PULSE GENERATOR MOVED FROM THE LEFT SIDE TO THE RIGHT SIDE. DURING THE SURGERY, CAUTERY CAME INTO CONTACT WITH THE DEVICE WHICH THEN EXHIBITED BACKUP VVI OPERATION. IT WAS CLINICALLY RESOLVED BY A SUCCESSFUL SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19537 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |