MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for DB-2201-45DC manufactured by Boston Scientific Neuromodulation.
[188211650]
Additional suspect medical device component involved in the event: model: db-2201-45dc, serial/lot: (b)(4), description: lead kit 45cm.
Patient Sequence No: 1, Text Type: N, H10
[188211651]
A report was received that the patient experienced high impedances on several contacts. However, the contacts with high impedances were turned off and other contacts were used instead. The patient also experienced a burning sensation in their feet for about twenty days. Prior to the implant procedure, the patient could not mobilize due to a high degree of stiffness, which resulted in the patient having complete dependence on other people. After the implant procedure, the patient continues to have a high level of stiffness but is able to walk without the help of others. In addition, the patient expressed that since the implant procedure, he feels very anxious and cannot sleep more than one hour despite taking medication. A computed tomography (ct) scan was performed and showed the displacement of the right lead, located in the frontal part of the brain, and the left lead in the globus pallidus internus (gpi). Since the patients response to the changes in therapy were not effective, the physician decided to turn off the device. The patient then underwent a revision procedure to explant the entire system. The patient is doing well postoperatively. All explanted devices were discarded by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01475 |
| MDR Report Key | 9890655 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2020-03-27 |
| 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 | TALAR TAHMASIAN |
| Manufacturer Street | 25155 RYE CANYON LOOP |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6619494863 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | ROAD 698, LOT NO. 12 |
| Manufacturer City | DORADO PR 00646-260 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00646-2602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MHY |
| Date Received | 2020-03-27 |
| Model Number | DB-2201-45DC |
| Catalog Number | DB-2201-45DC |
| Lot Number | 678910 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION |
| Manufacturer Address | 25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |