MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dementia (1808); Cognitive Changes (2551)

Event Date 02/13/2015

Event Type  Injury  

Event Description

Lilleeng, b., gjerstad, m., baardsen, r., dalen, i., larsen, j.P.The long-term development of non-motor problems after stn-dbs.Acta neurologica scandinavica.2015 mar 6 2015: doi: 10.1111/ane.12391.Summary: stimulation of the subthalamic nucleus (stn-dbs) is an established treatment with long-term beneficial effects on motor sym ptoms in patients with parkinson¿s disease (pd).The long-term development of non-motor problems after stn-dbs is not fully understood.In this study, we have studied how non-motor problems develop in patients with and without stn-dbs.We collected data from a prospectively followed cohort of patients that had been operated with stn-dbs 6¿9 years before final examination and compared our findings to the longitudinal development of non-motor problems in a non-operated, comparable reference population.In general, the non-motor problems of advanced pd seem to develop independently of treatment with stndbs.We found that depressions do not worsen after stn-dbs, and the montgomery and aasberg depression rating scale score in operated patients was substantially reduced from pre-operatively to post-operatively.Further, fatigue may represent an important unrecognized side effect of long-term stimulation, as fatigue was found to increase rapidly in operated patients already a year after surgery and continued to increase trough the 6- to 9-year follow-up.The non-motor problems of advanced pd seem to develop independently of treatment with stn-dbs.This may influence the strategy for choice of when to perform this therapy for eligible patients.Reported events: 1.8 patients with stn-dbs for parkinson¿s disease had hallucinations at last follow-up 6-9 years after surgery.2.2 patients with stn-dbs for parkinson¿s disease had hallucinations 1-1.5 years after surgery.3.5 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease developed dementia at last visit 6-9 years after implant surgery according to the diagnostic and statistical manual of mental disorders, third edition, revised (dsm-iii-r) criteria.All five developed dementia between one year after surgery and final visit.It was noted that the mean mini-mental state examination (mmse) score was 23.4 at last study visit.4.4 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease did not have functioning devices.The source literature did not include any specific device information.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.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, product type: implantable neurostimulator.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4771898
• MDR Text Key: 5787617
• Report Number: 3007566237-2015-01316
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P960009
• 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: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• 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: 04/21/2015
• 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): Other
• Patient Age: 00060 YR