MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2012-08-13 for MICRO-PACE 4570 manufactured by Pace Medical, Inc..
[2861423]
Pace medical was notified on may 25, 2011 by (b)(6) via letter that unit had a fault.
Patient Sequence No: 1, Text Type: D, B5
[10127578]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218087-2012-00029 |
| MDR Report Key | 2699066 |
| Report Source | 01,07,08 |
| Date Received | 2012-08-13 |
| Date Mfgr Received | 2011-05-26 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2012-08-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 310 SOUTH STREET SUITE 2 |
| Manufacturer City | PLAINVILLE MA 02762 |
| Manufacturer Country | US |
| Manufacturer Postal | 02762 |
| Manufacturer Phone | 5083163861 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-PACE |
| Generic Name | TEMPORARY CARDIAC PACEMAKER |
| Product Code | JOQ |
| Date Received | 2012-08-13 |
| Returned To Mfg | 2011-05-25 |
| Model Number | 4570 |
| Catalog Number | 4570 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PACE MEDICAL, INC. |
| Manufacturer Address | PLAINVILLE MA 02762 US 02762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-13 |