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 2012-03-28 for MICRO-PACE 4580 manufactured by Pace Medical, Inc..
[2578782]
Pace medical was notified (b)(6) 2012 by mr (b)(6) via email, a follow up telephone conversation that a ref 4580 micro-pace temporary cardiac pacemaker was in use at the time of the pt's death. At this time, there is no indications that the device was involved with the pt's death. No report has been filed by the hospital or medical professional. Pace medical, through its european rep, (b)(4), is following up on this incident and has requested that the device and any info such as an eck recording be sent to the company for analysis. The serial number (b)(4), has not been confirmed by the user as the device in operation but is "thought" to be the device. Further investigation has been requested through the distributor by pace medical to identify the exact serial number if possible. This is an initial report and contains all known info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218087-2012-00002 |
| MDR Report Key | 2521024 |
| Report Source | 01,07,08 |
| Date Received | 2012-03-28 |
| Date of Event | 2012-03-26 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-04-09 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 310 SOUTH ST. SUITE 2 |
| Manufacturer City | PLAINVILLE MA 02726 |
| Manufacturer Country | US |
| Manufacturer Postal | 02726 |
| Manufacturer Phone | 5083163861 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-PACE |
| Generic Name | TEMPORARY CARDICAC PACEMAKER |
| Product Code | JOQ |
| Date Received | 2012-03-28 |
| Model Number | 4580 |
| Catalog Number | 4580 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2012-03-28 |