MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Event Description

Sobstyl, m., zabek, m., mossakowski, z., zaczynski, a.Pallidal deep brain stimulation in the treatment of meige syndrome.Neurologia i neurochirurgia polska.2014;48(3):196-199.Doi: 10.1016/j.Pjnns.2014.05.008.Summary: meige syndrome (ms) is characterized by blepharospasm, facial, oromandibular, and often cervical dystonia.The medical treatment of this condition is challenging and unsuccessful over long time.Recent case reports and small clinical series showed that bilateral deep brain stimulation (dbs) of globus pallidus pars interna (gpi) improves dystonic features of ms validated by burke-fahn-marsden dystonia rating scale (bfmdrs).We report on our experience in using bilateral gpi dbs in 3 cases of ms.We present short-term (3 months) follow-up as well long-term (from 8 months to 36 months) results.Preoperative and postoperative bfmdrs assessments were performed on each patient.The postoperative bfmdrs scores was done when both stimulators were switched on and compared to baseline scores.Bilateral gpi dbs reduced the bfmdrs total movement score by 66% at short-term follow-up, and by 75% at long-term follow-up when compared to baseline scores.The bfmdrs total disability score was reduced by 34% at short-term follow-up, and by 47% at long-term follow-up when compared to baseline scores.Our results showed that bilateral gpi dbs in ms is effective and safe, if conservative treatment options failed.The benefit is not only observed at short-term 3 months period but is maintained at long-term follow-up ranging from 8 to 36 months.Reported event: one patient required a repeated surgery due to dislocation of the implantable neurostimulator (ins).The source literature did not include specific device information.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3977635
• MDR Text Key: 4755437
• Report Number: 3007566237-2014-02174
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/04/2014
• 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: 00048 YR