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

Model Number 37612

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 08/27/2016

Event Type  Injury  

Event Description

Krause, p., lauritsch, k., lipp, a., horn, a., weschke, b., kupsch, a., kiening, k.L., schneider, g-h., kuhn, a.A.Long-term results of deep brain stimulation in a cohort of eight children with isolated dystonia.Journal of neurology.2016.Doi 10.1007/s00415-016-8253-6.Summary: our study presents the first blinded video rating assessment of the short- and long-term effects of pallidal dbs in children with idiopathic or hereditary isolated dystonia.Reported event: patient 2: a (b)(6) female patient with deep brain stimulation (dbs) for dystonia experienced dislocation of the implantable neurostimulator (ins) requiring revision.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6060622
• MDR Text Key: 58503654
• Report Number: 3007566237-2016-03750
• 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,Followup
• Report Date: 10/27/2016

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: 37612
• Device Catalogue Number: 37612
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: 09/30/2016
• Supplement Dates FDA Received: 09/26/2017
• 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: 12 YR