MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-01 for DBS 3387 NA manufactured by Medtronic Puerto Rico Operations.
[503258]
On 7/30/06, the manufacturer was notified that the left burr hole incisional site had a scab remaining from surgery in approx two months earlier. Infectious disease physician recommended continued observation. The patient arrived at pre-planned unscheduled study visit on two days prior to original date, stating a "hole" occurred on four days earlier, but the patient had not notified physician. No infectious process. The patient was seen by neurology wound care service and awaited plastic surgery consult. On the following month, the hcp reported the patient went home on one day after the original date, despite risks and benefits explained to the patient by the surgical and infectious disease physicians. The patient agreed to be admitted on the following evening, for intravenous antibiotic therapy for head wound culture of a few staphylococcus aureus. The left dbs electrode was explanted one day later, by neurosurgery with primary wound closure by plastic surgery service without complications. Preliminary cultures were negative. Patient to have picc line inserted for home health antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2006-01482 |
| MDR Report Key | 757228 |
| Report Source | 05 |
| Date Received | 2006-09-01 |
| Date of Report | 2006-08-07 |
| Date of Event | 2006-07-24 |
| Date Mfgr Received | 2006-08-07 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2006-09-06 |
| 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 | 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, K.M 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 | 2006-09-01 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0421698V |
| ID Number | NA |
| Device Expiration Date | 2008-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 745131 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS |
| Manufacturer Address | ROAD #149, KM. 56.3 CALL BOX 6001 VILLALBA PR 00766 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2006-09-01 |