MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-03-23 for DBS 3387 NA manufactured by B.v.
[16642279]
The pt underwent implantation of two 3387-40 electrodes within the stn in 2005. The pt received antibiotic prophylaxis for 48 hrs perioperatively. Immediate postop ct showed some subdural air with optimal electrode location. The morning of postop day 2, the pt was drowsy, confused, and falling to the left side. He was noticeably bradycardic. Ct showed edema and air around the right electrode. He was treated with mannitol and dexamethasone and improved over the next 36 hrs. On postop day 4, he again became drowsy and confused and was taken to the or where the right sided electrode was removed. Broad spectrum antibiotics were started. Fluid from under the skin on both sides and from the brain around the right electrode were sent for microscopy and culture. Microscopy was negative for inflammation and cultures were negative. He improved over the next 12 hrs, but was then noted to be falling to the right side and the confusion remained. Ct image showed the same process around the left electrode too. He was returned to the or and the left electrode and the remainder of the implanted system, including the ipg, were removed. The pt has made a slow and steady improvement. Antibiotics and mannitol have been stopped and dexamethasone was increased. He has not developed fever, leucocytosis or features of meningeal irritation. He has occasional moments of confusion and return of parkinsonian symptoms. Subsequent info reported by the hcp in january 2007 shows the pt eventually made a complete recovery; allergy tests were negative. See mfr report number 2182207200501635.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000033-2007-01086 |
| MDR Report Key | 832587 |
| Report Source | 01,05 |
| Date Received | 2007-03-23 |
| Date of Report | 2005-10-02 |
| Date of Event | 2005-09-30 |
| Date Mfgr Received | 2005-10-02 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2007-04-02 |
| 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 | LISA WEIK |
| Manufacturer Street | 710 MEDTRONIC PKWY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635051004 |
| Manufacturer G1 | B.V. |
| Manufacturer Street | WENCKEBACHSTRAAT 10 |
| Manufacturer City | KERKRADE BV 6466NC |
| Manufacturer Country | * |
| Manufacturer Postal Code | 6466 NC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBS |
| Generic Name | MHY |
| Product Code | GYZ |
| Date Received | 2007-03-23 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0546325V |
| ID Number | NA |
| Device Expiration Date | 2009-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 819907 |
| Manufacturer | B.V |
| Manufacturer Address | WENCKEBACHSTRAAT 10 KERKRADE, BV * 6466 NC |
| 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. Required No Informationntervention | 2007-03-23 |