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 2017-04-20 for RESTORE ADVANCED 37713 manufactured by Medtronic Neuromodulation.
[73327185]
Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. The device was used for an off label indication. Concomitant medical products: product id neu_unknown_lead, product type: lead. Product id neu_unknown_ext, product type: extension.
Patient Sequence No: 1, Text Type: N, H10
[73327186]
De vloo, p. , raymaekers, s. , van kuyck, k. , luyten, l. , gabriels, l. , nuttin, b. Rechargeable stimulators in deep brain stimulation for obsessive-compulsive disorder: a prospective interventional cohort study. Neuromodulation. 2017. Doi: 10. 1111/ner. 12577. Summary: background: from 1999 onwards, deep brain stimulation (dbs) has been proposed as an alternative to capsulotomy in refractory cases of obsessive-compulsive disorder (ocd). Although rechargeable implantable pulse generators (ripgs) have been used extensively in dbs for movement disorders, there are no reports on ripgs in patients with a psychiatric dbs indication, and even possible objections to their use. Objective: we aim to evaluate ripgs in ocd in terms of effectiveness, applicability, safety, and need for ipg replacement. Methods: in this prospective before-after study recruiting from 2007 until 2012, ocd patients requiring at least one ipg replacement per 18 months were proposed to have a ripg implanted at the next ipg depletion. Ocd severity was the primary outcome. Ten patients were analyzed. Results: psychiatric symptoms and global functioning remained stable in the two years after as compared to the two years before ripg implantation. Over the same period, the prescribed ocd medication doses did not increase and the dbs stimulation parameters were largely unaltered. Until the end of the follow-up (mean 4 3/4 years; maximum seven years), the dbs-related surgery frequency decreased and there were no ripg replacements. During the first few weeks after implantation, two patients obsessively checked the ripg, but afterwards there were no signs of compulsively checking or recharging the ripg. Two patients experienced ripgoverdischarges (five occurrences in total). Conclusions: this is the first report on ripgs in dbs for ocd patients. The use of ripgs in this population appears to be effective, applicable, and safe and diminishes the need for ipg replacements. Reported events: 2. Patient 8: a (b)(6) (at implant) female patient with bilateral deep brain stimulation (dbs) for obsessive compulsive disorder (ocd) underwent unilateral electrode and extension wire revision due to breakage with high impedance over an electrode contact. 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
[98785522]
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
| Report Number | 3007566237-2017-01516 |
| MDR Report Key | 6508529 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-20 |
| 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 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 |
| Brand Name | RESTORE ADVANCED |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | MFR |
| Date Received | 2017-04-20 |
| Model Number | 37713 |
| Catalog Number | 37713 |
| 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 | 2017-04-20 |