MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-06-08 for NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[77231677]
Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature. The device was used for an off label indication. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[77231678]
Lim, lh. , noma fitzrol, d. , rajapathy, sk. , tan, yc. , sanihah, ah. , kandasamy, r. , wan hassan, wmn. , badrisyah, i. , abdul rahman izaini, g. , zamzuri, i. , tharakan, j. , nunta-aree, s. , jafri malin, a. Deep brain stimulation (dbs) for movement disorders: an experience in hospital universiti sains malaysia (husm) involving 12 patients. Malaysian journal of medical sciences. 2017;24(2):87-93. Doi: 10. 21315/mjms2017. 24. 2. 11. Summary: deep brain stimulation (dbs) was first introduced in 1987 to the developed world. As a developing country malaysia begun its movement disorder program by doing ablation therapy using the radionics system. Hospital universiti sains malaysia a rural based teaching hospital had to take into consideration both health economics and outcomes in the area that it was providing neurosurgical care for when it initiated its deep brain stimulation program. Most of the patients were from the low to medium social economic groups and could not afford payment for a dbs implant. We concentrated our dbs services to parkinson's disease, tourette's syndrome and dystonia patients who had exhausted medical therapy. The case series of these patients and their follow-up are presented in this brief communication. Reported events: 1. Case 12: a (b)(6) male with deep brain stimulation (dbs) of the medial thalamus for tourette? S syndrome experienced an allergic reaction to the device shortly after implant so the device was removed. It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
[100188147]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02268 |
| MDR Report Key | 6624659 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-06-08 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-08 |
| 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 WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MFR |
| Date Received | 2017-06-08 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-08 |