MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-01 for DBS 3387 NA manufactured by Medtronic, Inc..
[239863]
Hcp reported that he had treated the patient with antibiotics after the patient reportedly was able to see "wires from open wound near ear". The patient was reported to be doing fine and was going to see another doctor for removal of the device because of the infection. A follow up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
[22181308]
B5- the hcp reports the onset of the infection was approximately 1/2002 as evidenced by redess, swelling, drainage, and incision wound opening at the "skull connector site" the pt was treated with iv and oral antibiotics. The infection resolved with no drug withdrawal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2002-00066 |
| MDR Report Key | 375084 |
| Report Source | 05 |
| Date Received | 2002-02-01 |
| Date of Report | 2002-01-05 |
| Date Mfgr Received | 2002-01-05 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2002-02-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VICKI SCHREIBER |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 7635147316 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2002-02-01 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0101879V |
| ID Number | NA |
| Device Expiration Date | 2005-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 364207 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVE NE 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 | 2002-02-01 |