MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-13 for MICRO PACE 4580 manufactured by Pace Medical, Inc.
[15864429]
Pace medical was notified on 09/30/2011 by (b)(6) from apcc netherlands by letter that unit had a fault.
Patient Sequence No: 1, Text Type: D, B5
[15871855]
Customer reported a display error message. The device was examined for the display error message mentioned "mall" which is an impossible code for the display to produce. After much discussion it was discovered this was a translation issue from the french language and the customer meant to say "poor" sensing. Sensing tests were performed and the device appeared to function normally. Working with the ebme staff at the hosp it was uncovered that heart wires with very high impedances could cause sensing issues. The devices were recalled and waivers were applied to them. All affected serial numbers were recalled to be modified. All devices were outside the united states. Reason for complaint: device sensing circuit was modified to work better with high impedance heart wires.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218087-2012-00056 |
| MDR Report Key | 2699200 |
| Report Source | 01,07 |
| Date Received | 2012-08-13 |
| Date Mfgr Received | 2011-09-30 |
| Device Manufacturer Date | 2011-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 310 SOUTH ST, STE 2 |
| Manufacturer City | PLAINVILLE MA 02762 |
| Manufacturer Country | US |
| Manufacturer Postal | 02762 |
| Manufacturer Phone | 5083163861 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2011-09-30 |
| Model Number | 4580 |
| Catalog Number | 4580 |
| 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 |