MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA SC

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Migration or Expulsion of Device (1395); Low Battery (2584); Material Deformation (2976)

Patient Problems Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)

Event Date 11/25/2017

Event Type  Injury  

Manufacturer Narrative

Date of event.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.Information references the main component of one of the systems involved in the reported events; other applicable components are: product id: neu_unknown_ext, lot# unknown, product type: extension.Product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: 37612, lot# unknown, product type: implantable neurostimulator franzini, a., ranieri, r., gambini, o., messina, g.Manipulating an internal pulse generator until twiddler's syndrome in a patient treated with deep brain stimulation for obsessive-compulsive disorder.Acta neurochir (wien).2017.Doi: 10.1007/s00701-017-3412-9.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: background: twiddler¿s syndrome consists of rotation or manipulation of an implantable pulse generator (ipg) in its subcutaneous pocket by a patient, thus causing hardware malfunction.Methods: this syndrome is being reported more frequently in patients treated with deep brain stimulation (dbs).Results: we report the case of a woman who had received bed nucleus of stria terminalis (bnst) electrodes for obsessive-compulsive disorder (ocd) and developed twiddler¿s syndrome a few months after surgery, causing hardware malfunction due to obsessive manipulation of the ipg.Conclusion: the patient did not have compulsions related to touching objects at admission, thus making it difficult to foresee and prevent ts.Reported events: a (b)(6)-year-old woman with bilateral deep brain stimulation (dbs) of the bed nucleus of stria terminalis (bnst) electrodes for obsessive-compulsive disorder (ocd) experienced depletion of their left implantable neurostimulator (ins) along with a worsening of their clinical presentation after approximately 6-7 months in which they had achieved ¿slow but evident clinical improvement in ocd and general functioning.¿ with the right ins also reportedly getting low the authors decided to replace them with two rechargeable ins¿s.They wrote that during the replacement surgery the left extension was observed to be extensively coiled on itself.The patient¿s family reported that the patient had frequently manipulated the device at both the thoracic and extension/lead connector positions, and the authors hypothesized that the braiding of the extension was caused by rotation of the ins in the loose connective tissue of the infraclavicular pocket.Postoperative impedance readings on the right side were normal, but high impedances were found on all contacts of the left lead.X-ray imaging confirmed there was braiding and fraying of the extension which continued to the extracranial part of the lead.Another surgery was performed to replace the left extension and to secure the ins to the muscle fascia with silk sutures.Six months later there had reportedly been no recurrence of twiddler¿s syndrome.The authors reported that the patient was implanted with an activa sc neurostimulator, which was later replaced with an activa rc rechargeable neurostimulator, but the model number of activa sc was not provided.It was not possible to ascertain any further specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: ACTIVA SC
• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7298068
• MDR Text Key: 101000482
• Report Number: 3007566237-2018-00570
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• 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: 51 YR