MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-22 for DBS 3387 NA manufactured by Medtronic Puerto Rico Operations.
[368221]
Hcp reported pt presented with obvious external signs of an infection in 2005. The pt was treated with oral antibiotics and is currently receiving iv antibiotics. Hcp expects a complete recovery. The device was explanted and returned to the manufacturer for analysis. A follow-up report will be sent if add'l info is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000153-2005-00634 |
| MDR Report Key | 594612 |
| Report Source | 05 |
| Date Received | 2005-04-22 |
| Date of Report | 2005-04-07 |
| Date of Event | 2005-03-18 |
| Date Mfgr Received | 2005-04-07 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-04-26 |
| 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 PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS |
| Manufacturer Street | ROAD #149, KM. 56.3 CALL BOX 6001 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBS |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2005-04-22 |
| Returned To Mfg | 2005-04-07 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0421598V |
| ID Number | NA |
| Device Expiration Date | 2008-04-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 584443 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS |
| Manufacturer Address | RD. 149, KM. 56.3 CALL BOX 6001 VILLALBA PR 00766 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD |
| Baseline Model No | 3387 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-22 |