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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Seizures (2063); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Romito, l.M., zorzi, g., marras, c.E., franzini, a., nardocci, n., albanese, a.Pallidal stimulation for acquired dystonia due to cerebral palsy: beyond 5 years.European journal of neurology : the official journal of the european federation of neurological societies.2014:doi:10.1111/ene.12596.Summary: there is increasing evidence that deep brain stimulation (dbs) of the globus pallidus internus (gpi) is effective in patients with idiopathic or inherited generalized dystonia.There is comparatively less experience about the effects of gpi dbs on acquired dystonia, particularly dystonia due to cerebral palsy (dcp).Clinical and demographic outcome predictors for dbs in dystonia syndromes are also poorly defined.Our aim was to examine the efficacy and safety of gpi dbs for the treatment of generalized dcp.Fifteen patients with dcp up to 6.2 years after dbs surgery were studied.Only mild limb spasticity or mild static brain magnetic resonance imaging abnormalities were acceptable for inclusion.Dystonia severity and disability were assessed by the burke_fahn_marsden dystonia rating scale (bfmdrs), and health-related quality of life was assessed by the short form general health survey (sf-36) scale.The amount of energy delivered was calculated, and adverse events and side effects were collected.At last follow-up, bfmdrs motor score improved on average by 49.5%, and the disability score improved by 30%.Health-related quality of life improved in most patients.Age at implant, age at onset and disease duration did not correlate to outcome, whilst higher pre-operative dystonia severity and occurrence of spasticity were associated with poorer outcome.The patients received a stable amount of energy after the first 2 years post-implant and throughout all the observation period.There were few serious adverse events or side effects.The outcome was encouraging in the majority of dcp patients, with a stable outlook and a good safety profile.Reported events: 1.1 patient with deep brain stimulation (dbs) for generalized dystonia due to cerebral palsy experienced a transient seizure.2.1 patient with dbs for generalized dystonia due to cerebral palsy experienced hardware infection.It was noted that hardware re-implant or appropriate medical therapy resolved the problem.3.1 patient with dbs for generalized dystonia due to cerebral palsy experienced lead migration.It was noted that the cause of the migration was unexplained.The reporter stated that lead/hardware re-implant or appropriate medical therapy resolved the problem.4.1 patient with dbs for generalized dystonia due to cerebral palsy experienced unexplained switching-off of the implantable neurostimulator (ins).It was noted that this caused significant acute motor worsening.5.1 patient with dbs for generalized dystonia due to cerebral palsy experienced extra-cranial lead damage occurring during surgical procedure.The reporter stated that the patient suffered extra-cranial lead damage following head trauma.It was noted that lead/hardware re-implant or appropriate medical therapy resolved the problem.The source literature included the following device specifics: lead model 3389 and implantable neurostimulators soletra or activa sc further information has been requested; a supplemental report will be submitted if additional information is received.See attached literature article.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority 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_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: 3389 lot# unknown serial# implanted: explanted: product type: lead.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator product id: 3389, lot# unknown serial# implanted: explanted: product type: lead.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator.Product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: neu_ins_stimulator lot# unknown serial# implanted: explanted: product type: implantable neurostimulator.Product id: 3389 lot# unknown serial# implanted: explanted: 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: 4376398
• MDR Text Key: 19608263
• Report Number: 3007566237-2014-03849
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 12/04/2014

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: 12/04/2014
• Initial Date FDA Received: 12/31/2014
• 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): Other; Required Intervention
• Patient Age: 00029 YR