MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-01-09 for DBS 3387 NA manufactured by Neurological Div, Medtronic, Inc..
[549041]
The pt reported to the mfr in september 2006 that infection had been diagnosed. The pt indicated treatment rec'd by the physician was to clean out the affected area in the head, but the reported infection resurfaced. On 9/11/06, the pt provided that the device would be removed on the side of infection. The affected side was not reported. Add'l info was requested from the physician. On 12/18/06, the hcp reported the pt presented with signs of infection that included drainage and incisional wound opening. The date of onset was not provided. It was unk if perioperative antibiotics were administered and the pt does not have meningitis. The physician reported the primary location of the infection was the lead track. The affected side was not reported. The lead was implanted in 1998. Info rec'd shows a culture was obtained, but the culture source was not indicated. The type of organism cultured was unk. Iv antibiotics were instituted to treat the reported infection. No report of system explant rec'd from the hcp. Review of the mfr device registration system shows new right-side dbs system was placed on 11/17/06. The product has not been rec'd by the mfr for analysis. The pt outcome per hcp report shows the infection has resolved.
Patient Sequence No: 1, Text Type: D, B5
[8055047]
Review of mfr device registration system shows identical mfg lot number (l57274) of bilateral lead products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182207-2007-00120 |
| MDR Report Key | 803639 |
| Report Source | 04,05 |
| Date Received | 2007-01-09 |
| Date of Report | 2006-09-11 |
| Date of Event | 2005-12-01 |
| Date Mfgr Received | 2006-09-11 |
| Device Manufacturer Date | 1998-10-01 |
| Date Added to Maude | 2007-01-16 |
| 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 PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635051004 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 800 53RD AVENUE 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 | MHY |
| Product Code | GYZ |
| Date Received | 2007-01-09 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | L57274 |
| ID Number | NA |
| Device Expiration Date | 2002-10-19 |
| 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 | 791144 |
| Manufacturer | NEUROLOGICAL DIV, 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. Required No Informationntervention | 2007-01-09 |