MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-23 for DBS 3389 NA manufactured by Medtronic Puerto Rico Operations Co., Mpri.
[18329182]
In may 2006, the patient was showing aggressive tendencies and suffered minor injuries during a fight with other nursing home residents. The patient was seen by the hcp and the dbs system was adjusted to a lower setting. The patient suffers from dementia, previous stroke, and hearing loss. These factors create frustation for the patient which combined with programmed settings on the dbs device lead to behavioral changes. The hcp noted good placement of the leads and good device function. The patient was last seen by the hcp in june 2006 and is doing well. The device remains implanted and active.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000153-2006-01022 |
| MDR Report Key | 728971 |
| Report Source | 05 |
| Date Received | 2006-06-23 |
| Date of Report | 2006-05-26 |
| Date Mfgr Received | 2006-05-26 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2006-06-28 |
| 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 | NIKOLE RAHN |
| Manufacturer Street | 710 MEDTRONIC PARKWAY LN 145 |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635051077 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS |
| Manufacturer Street | ROAD # 149, K.M 56.3, CALL BOX 6001 |
| Manufacturer City | VILLABA 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 | 2006-06-23 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | J0437175V |
| ID Number | NA |
| Device Expiration Date | 2008-07-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 717255 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO., MPRI |
| Manufacturer Address | RD. 149, KM. 56.3 CALL BOX 6001 VILLALBA PR 00766 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD |
| Baseline Model No | 3389 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-23 |