MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-25 for DBS 3387 NA manufactured by Medtronic Puerto Rico Operations Co., Mpri.
[383078]
Hcp reported infection of deep brain stimulation surgical sites. Patient presented with drainage, was treated with both iv and oral antibiotics and device explantation. Mri brain scan revealed probable glosis along dbs tracts. No abcess seen. The type of organism found was staphylococcus and mrsa. The device was explanted and returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
[7790268]
Attempts were made to obtain additional information from the user facility regarding this event. The information submitted reflects all relevant data received. Notification that this event does not meet the user facilitys reporting criteria will be filedevaluation summary tcp023381v no anomalies found; partial lead in segments returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000153-2005-00812 |
| MDR Report Key | 607773 |
| Report Source | 05 |
| Date Received | 2005-05-25 |
| Date of Report | 2005-04-27 |
| Date of Event | 2004-10-04 |
| Date Mfgr Received | 2005-04-27 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2005-05-31 |
| 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 | 2005-05-25 |
| Returned To Mfg | 2005-04-27 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0206699V |
| ID Number | NA |
| Device Expiration Date | 2006-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 05 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 597563 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO., MPRI |
| 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 | 2005-05-25 |