MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problems Break (1069); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6508529
• MDR Text Key: 73327185
• Report Number: 3007566237-2017-01516
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR