MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-22 for DBS 3380 NA manufactured by Medtronic Inc..
[17822713]
Literature report of a patient with a past history of mi, suffered from right thalamic bleeding, and developed left severe action tremor. The patient had a neurostimulation system for tremor implanted in 1992. The patient received tremor relief with stimulation. In 1995, the patient underwent emergency cardioversion at 100 j. And 200 j. For paroxysmal atrial fibrillation. One paddle was placed close to the rf receiver implanted subcutaneously at the anterior chest wall. After successful cardioversion, the action tremor disappeared completely. A ct scan obtained later, showed the 3380 lead artifact and could not demonstrate any clearly destroyed structures including lesion or thalamic bleeding. The thalamotomy effect has lasted for 4 years. The authors conclude that the moment changes in the high-voltage electrical current of the chest wall evoked changes in the electromagnetic fields, and radiofrequency evoked electrical flow occurred in the radiofrequency receiver connected to the stimulating electrode. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2001-00279 |
| MDR Report Key | 349063 |
| Report Source | 05 |
| Date Received | 2001-08-22 |
| Date of Report | 2001-08-21 |
| Date Mfgr Received | 2001-08-21 |
| Date Added to Maude | 2001-08-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VICKI SCHREIBER |
| Manufacturer Street | 800 53RD AVE. NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 7635147316 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-08-22 |
| Model Number | 3380 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 338380 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD |
| Baseline Model No | 3380 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-08-22 |