MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-26 for SYNERGY 7427V NA manufactured by Medtronic Puerto Rico Operations Co. Medrel.
[29213960]
Medwatch reports removal of infected stimulator. Refer to attached mfr # (b)(4). The device was explanted but not returned to the manufacturer for analysis. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2004-01117 |
| MDR Report Key | 5161690 |
| Date Received | 2004-08-26 |
| Date of Report | 2004-08-04 |
| Date of Event | 2004-04-14 |
| Date Mfgr Received | 2004-08-04 |
| Device Manufacturer Date | 2002-12-28 |
| Date Added to Maude | 2015-10-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PKWY. |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. MEDREL |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYNERGY |
| Product Code | NPM |
| Date Received | 2004-08-26 |
| Model Number | 7427V |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2003-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 25 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. MEDREL |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-26 |