FDA Adverse Event
Other
Summary report: N
MICRO-PACE
MDR report key: 2699166
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00034
- 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
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETURNED THE DEVICE WITH THE COMPLAINT THAT ICD DISPLAY WAS NOT FUNCTIONING PROPERLY. THE DEVICE WAS EXAMINED IT WAS DETERMINED THAT THE LCD DISPLAY WAS NOT FUNCTIONING AS REQUIRED. IT WAS REPLACED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED AND IT PASSED ALL TESTS AND RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: UNK - RANDOM DISPLAY FAILURE.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON JUNE 14, 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 |