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

Model Number 3387

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

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 patient and device information and additional information regarding the reported events.(b)(4).

Event Description

Krause, p., bruggemann, n., volzmann, s., horn, a., kupsch, a., schneider, g.H., lohmann, k., kuhn, a.Long-term effect on dystonia after pallidal deep brain stimulation (dbs) in three members of a family with a thap1 mutation.Journal of neurology.2015.Doi 1 0.1007/s00415-015-7908-z summary: deep brain stimulation (dbs) of the globus pallidus internus (gpi) is an established treatment in patients with severe dystonia.However, factors predicting outcome are largely unknown and motor improvement in dyt6 patients after dbs has been reported to be poorer as compared to, e.G., dyt1 patients.Here, we report the course of clinical improvement for up to 11 years of pallidal dbs in three male patients belonging to the same family with early-onset generalized or segmental dystonia due to a heterozygous thap1 gene mutation (dyt6).All patients showed an initial effective response to pallidal dbs with a mean of 56.9 ± 11.7 % improvement in the burke¿fahn¿marsden dystonia motor and 45.5 ± 22.4 % in the disability score at 1-year follow-up.The long-term outcome of pallidal dbs was favorable in two patients (39, 67 % motor improvement, respectively).Our findings demonstrate that motor improvement is variable and may depend on disease severity, disease duration, and clinical presentation.Overall, our observation supports pallidal dbs as an important treatment option in patients with dyt6 dystonia.Reported event: it was reported that the patient, who had pallidal deep brain stimulation (dbs) for severe generalized dystonia, had a clinically meaningful response initially, with 70.5% improvement in motor scores and 88.9% improvement in disability scores at the one year follow-up.However, the whole dbs system had to be explanted due to local electrode infection nine years after implantation.Dystonic symptoms, pain, and degree of disability worsened rapidly without dbs, so that bilateral pallidal dbs electrodes were re-implanted soon after successful antibiotic treatment.The source literature included the following device specifics: lead model 3387 and implantable neurostimulators itrel ii or kinetra model 7428 further information has been requested; a supplemental report will be submitted if additional information is received.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5277363
• MDR Text Key: 33053201
• Report Number: 3007566237-2015-03710
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3387
• Device Catalogue Number: 3387
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• 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: 00029 YR