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 Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 01/11/2018

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.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#:.Frizon, l., may, fj., shao, j., maldonado-naranjo, al., nagel, sj., machado, ag.Outcomes following deep brain stimulation lead revision or reimplantation.In abstracts from the 21st annual meeting of the north american neuromodulation society, las vegas, nv, usa january 11-14, 2018.Neuromodulation 2018; doi: 10.1111/ner.12774.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Summary/reported events: five patients with deep brain stimulation (dbs) for parkinson's disease (pd) experienced a lead infection that necessitated lead removal and subsequent reimplantation.There was reportedly significant improvement in the contralateral motor scores after revision/reimplantation surgery.Seven patients with dbs for pd experienced suboptimal outcomes (limited benefit or side effects at low thresholds) leading to the lead(s) being revised.There was reportedly significant improvement in the contralateral motor scores after revision/reimplantation surgery.Two patients with dbs for pd experienced device failure requiring lead revision.There was reportedly significant improvement in the contralateral motor scores after revision/reimplantation surgery.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• 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; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7665083
• MDR Text Key: 113282295
• Report Number: 3007566237-2018-02001
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: 06/07/2018
• 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