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

Model Number NEU_INS_STIMULATOR

Device Problem Material Erosion (1214)

Patient Problem Skin Erosion (2075)

Event Date 06/01/2002

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article 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.Product id: 7495, product type: extension.(b)(4).

Event Description

Oh, m.Y., abosch, a., kim, s.H., lang, a.E., lozano, a.M.Long-term hardware-related complications of deep brain stimulation.Neurosurgery.2002; 50(6): 1268-1274; discussion 1274-1266.Summary: to determine the incidence of long-term hardware-related complications of deep brain stimulation (dbs).Long-term follow-up reveals that hardware-related complications occur in a significant number of patients.Factors that lead to such complications must be identified and addressed to maximize the important benefits of dbs therapy.Reported events: one (b)(6) female patient with deep brain stimulation (dbs) for parkinson's disease experienced erosion at the connector site 45 months after implant.It was noted that this patient likely had the hardware removed as a result; however, it was unclear what treatment was provided.The source literature included the following device specifics: lead model 3387, extension model 7495 and either implantable neurostimulator itrel ii or the x-trel receiver.Further information has been requested; a supplemental report will be submitted if additional information is received.

• 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 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: 5482218
• MDR Text Key: 39746936
• Report Number: 3007566237-2016-01268
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/05/2016
• 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: 00070 YR