FDA Adverse Event
Other
Summary report: N
MICRO-PACE
MDR report key: 2699180
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00045
- Event Type
- Other
- Date Received
- August 13, 2012
- Manufacturer
- PACE MEDICAL, INC
- Product Code
- JOQ
- PMA / PMN Number
- P920032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETURNED THE DEVICE WITH THE COMPLAINT THAT THE ATRIAL CHANNEL WAS NOT WORKING. THE DEVICE WAS EXAMINED AND FOUND THAT A TRACE NEEDED REPAIR. THE REPAIR WAS MADE. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TEST WERE PASSED AND WAS RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: POSSIBLE ROUGH HANDLING OR A SUDDEN IMPACT.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON 08/16/2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO-PACE | TEMPORARY CARDIAC PACEMAKER | JOQ | PACE MEDICAL, INC | 4570 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |