FDA Adverse Event
Other
Summary report: N
MICRO-PACE
MDR report key: 2699031
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00010
- Event Type
- Other
- Date Received
- August 13, 2012
- Manufacturer
- PACE MEDICAL, INC.
- Product Code
- DTE
- PMA / PMN Number
- P920032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO COMPANY STATING THE ATRIAL OUTPUT WAS OUTSIDE SPECIFICATIONS. DEVICE WAS ANALYZED AND FAULT WAS OBSERVED. THE ATRIAL TERMINAL WAS LOOSE. THE TERMINAL WAS TIGHTENED. THE DEVICE WAS RECALIBRATED AND FINAL TESTED. ALL TESTS WERE NOMINAL. THE DEVICE WAS RETURNED TO THE CUSTOMER. TERMINAL LOOSENING MAY HAVE BEEN CAUSED BY ROUGH HANDLING OR A SUDDEN IMPACT.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON MARCH 17, 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 | DTE | PACE MEDICAL, INC. | 4570 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |