MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-10 for 5328 manufactured by Medtronic, Inc..
[21656807]
It was reported that during testing of the external pulse generator (epg), the biomedical engineer found that the output was low. The biomedical engineer used the 500 ohm load, along with other test loads, and tested two other stimulators, with no issue. The epg is no longer supported; therefore, an end-of-service life letter was emailed. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[22007541]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2013-03481 |
| MDR Report Key | 3510094 |
| Report Source | 05 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-10-29 |
| Date Added to Maude | 2014-03-21 |
| 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 Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2013-12-10 |
| Model Number | 5328 |
| Catalog Number | 5328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-10 |