MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-10-03 for MICRO-PACE 4580 manufactured by Pace Medical, Inc..
[3037071]
Dear (b)(6), we are not going to be able to get the serial number as it was not recorded and i am also almost sure that it was not a pacemaker related problem. I reported as, per our agreement just in case. There is still a lack of confidence in the 4580 and i am trying to get people to look at this rationally and give them a second (or should i say 3rd) trial as we discussed. I have now instigated a physiologist ward round each morning to check pacing and sensing on any 4580s on pts. Thanks for your prompt response. Kind regards, (b)(6). Dear (b)(6), i had another incident reported at the weekend of under-sensing on one of the above boxes. This was linked to a pt going into vf and subsequently dying. The whole episode is unclear and the ccitu did not isolate the box not report the incident properly; therefore, we have no way to knowing whether this was a real issue or not. From an observation, it was previously undersensing in aai mode which i don not think is an issue as atrial wires are notoriously bad for sensing. I am awaiting a clearer explanation of what happened and also for the pt's notes so i can see what is documented but i am slightly concerned that this could be a repeat. If so, we will have to withdraw the whole batch of them again. I will keep you updated when i have more info.
Patient Sequence No: 1, Text Type: D, B5
[10211157]
Pace medical has no data to proceed with regarding this alleged incident. Only anecdotal info is supplied by the user. Pace medical has requested additional data and it appears the user cannot provide any additional info and appears to believe the events are not related. It is our opinion the aai pacing does not precipitate vf. Pace medical will continue to monitor this situation and report as required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218087-2012-00058 |
| MDR Report Key | 2779592 |
| Report Source | 01,06 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-06-28 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-10-15 |
| 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 |
| Manufacturer City | PLAINVILL MA 02762 |
| Manufacturer Country | US |
| Manufacturer Postal | 02762 |
| Manufacturer Phone | 5083163861 |
| Single Use | 3 |
| Remedial Action | IN |
| 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 | 2012-10-03 |
| Model Number | 4580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PACE MEDICAL, INC. |
| Manufacturer Address | PLAINVILLE MA 02662 US 02662 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-03 |