MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-24 for DBS 3387 NA manufactured by Neurological Division, Medtronic, Inc..
[375871]
Hcp reported pt presented 8/04 with signs of infection of the device pocket. This includes swelling. Cultures of the device pocket were obtained and "subculture 2+ staph aureus" was the organism cultured. The pt was treated both iv and oral antibiotics and explant and replacement of the lead. Hcp reports the infection is now resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2004-01550 |
| MDR Report Key | 557088 |
| Report Source | 05 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-10-20 |
| Date of Event | 2004-10-13 |
| Date Mfgr Received | 2004-10-20 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2004-12-02 |
| 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 | LORI CLARK |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050815 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55421 |
| 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 | 2004-11-24 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0424900V |
| ID Number | NA |
| Device Expiration Date | 2008-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 546761 |
| Manufacturer | NEUROLOGICAL DIVISION, MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD FOR BRAIN STIMULATION |
| Baseline Model No | 3387 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STIM DBS LEAD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-24 |