FDA Adverse Event
Injury
Summary report: N
MINIATURE
MDR report key: 2696156
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00043
- Event Type
- Injury
- Date Received
- August 13, 2012
- Manufacturer
- PACE MEDICAL, INC.
- Product Code
- DTE
- PMA / PMN Number
- K870323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETURNED THE DEVICE WITH THE COMPLAINT THAT THE PACING RATE WAS HIGHER THAN THE SET RATE AND THE PT WAS INVOLVED IN CARDIAC ARREST. THE DEVICE WAS EXAMINED BY APC MEDICAL TECHNICIANS AND IT WAS FOUND THAT THERE WAS A FAULTY COMPONENT AND A BROKEN SOLDER JOINT. THE COMPONENT WAS REPLACED AND THE SOLDER JOINT WAS REPAIRED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: RANDOM COMPONENT FAILURE AND SOLDER JOINT FAILURE MAY HAVE BEEN THE RESULT OF ROUGH HANDLING OR A SUDDEN IMPACT.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON (B)(6) 2011 BY (B)(6) HOSPITAL VIA LETTER THAT UNIT HAD A FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIATURE | TEMPORARY CARDIAC PACEMAKER | DTE | PACE MEDICAL, INC. | EV4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |