FDA Adverse Event
Other
Summary report: N
MICRO-PACE
MDR report key: 2699066
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00029
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETURNED PRODUCT WITH A COMPLAINT THAT THERE WAS LOW OUTPUT ON THE VENTRICULAR CHANNEL. THE DEVICE WAS EXAMINED AND THE COMPLAINT CONFIRMED. THE DEVICE WAS REPAIRED, A COMPONENT REPLACED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR FAULT: RANDOM COMPONENT FAILURE.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON MAY 25, 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 |