FDA Adverse Event
Injury
Summary report: N
ENTITY DR
MDR report key: 1223482
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03222
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 7, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING PREPARED FOR FOOT SURGERY, HIS HEART RATE DROPPED TO 30-40 BEATS PER MINUTE (BPM) WITH A MAGNET ON THE DEVICE. THE PACEMAKER WAS NOT PACING, SO THE PATIENT WAS TRANSCUTANEOUSLY PACED WITH PADS. POST OPERATION, THE DEVICE WAS PROGRAMMED TO DDD MODE AT 70 BPM. THE NEXT DAY, THE PULSE GENERATOR WAS NOT PACING. THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5326L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |