MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-10 for DBS 3387 NA manufactured by Mnpro Mpri.
[365681]
Doctor reported changes in patient, i. E. Walk would become 'frozen', falling to one side. Doctor requested pt have ct scan. Nothing significant noted on the scan by different hcp. Doctor asked pt if pt would like to stay, pt elected to go home. Pt returned later with exaggerated pd symptoms. Doctor reviewed scan again, noticing what looked to be a 'little stroke' near active electrode (3), which has since become a hemorrhage. Pt was living independently; doctor currently looking at long term living arrangements. Doctor stated stimulator had been turned off - no date provided. No report of device explantation however doctor requested advice on device removal. A follow-up report will be sent if additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000153-2004-00759 |
| MDR Report Key | 529563 |
| Report Source | 05 |
| Date Received | 2004-06-10 |
| Date of Report | 2004-06-07 |
| Date Mfgr Received | 2004-06-07 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2004-06-15 |
| 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 | MNPRO |
| 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 | 2004-06-10 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | J0228218V |
| ID Number | NA |
| Device Expiration Date | 2006-10-15 |
| 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 | 518795 |
| Manufacturer | MNPRO MPRI |
| Manufacturer Address | ROAD #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. Hospitalization | 2004-06-10 |