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

Model Number NEU_INS_STIMULATOR

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 02/09/2013

Event Type  malfunction  

Event Description

Carvalho, k.S., sukul, v.V., bookland, m.J., koch, s.A., connolly, p.J.Deep brain stimulation of the globus pallidus suppresses post-traumatic dystonic tremor.Journal of clinical neuroscience : official journal of the neurosurgical society of australasia.2014;21(1):153-155.Doi:http://dx.Doi.Org/10.1016/j.Jocn.2013.02.009 summary: dystonic tremor is an unusual movement disorder that is highly disabling and difficult to treat medically.We describe an (b)(6) patient with dystonic tremor whose medical treatment failed, and was considered for surgery.The patient had a long-standing dystonic tremor and was recommended for globus pallidus (gp) deep brain stimulation.At 2 year follow-up, we observed substantial tremor suppression and best clinical effect with contact three, which, radiographically, is located in the internal globus pallidus/external globus pallidus transition area.The stimulation was more rostral than expected.We conclude that the gp is a potentially useful therapeutic target for dystonic tremor.Reported events: one (b)(6) male patient with globus pallidus (gp) deep brain stimulation (dbs) for dystonic tremor experienced a return of dystonic tremor completely unabated and at its preoperative baseline two years after the implant surgery.It was noted that the patient had previously had therapeutic effect.The reporter stated that the implantable neurostimulator (ins) was interrogated and noted to be off.The patient reported that the involuntary movement reemerged after passing through an airport security checkpoint.The reporter stated that the system was reactivated and reprogrammed to attempt further tremor suppression.The patient was reportedly reprogrammed using contact 3, which was noted to be at the medial border of the external globus pallidus.The reporter stated that the patient was successfully treated with unilateral pallidal stimulation.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

The actual event dates were not provided.This date is based on the date of publication of the article.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Product id 3387, lot# unknown; product type lead.(b)(6).

• 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: 3637060
• MDR Text Key: 4204629
• Report Number: 3007566237-2014-00525
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• 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: 02/10/2014
• 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 Age: 00020 YR