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

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Urinary Tract Infection (2120); Electric Shock (2554)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Pt age: please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Pt gender: please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided.Concomitant medical products: product id neu_ins_stimulator, product type: implantable neurostimulator.(x53).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Ostrem jl, san luciano m, dodenhoff ka, ziman n, markun lc, racine ca, de hemptinne c, volz mm, heath sl, starr pa.Subthalamic nucleus deep brain stimulation in isolated dystonia: a 3-year follow-up study.Neurology 2017; 88:1-11.Summary: the objective of this study was to report long-term safety and efficacy outcomes of a large cohort of patients with medically refractory isolated dystonia treated with subthalamic nucleus (stn) deep brain stimulation (dbs).Reported events: 1 patient with stn dbs for dystonia experienced surgery-related urinary tract infection within 12 months of implant.This was noted to be resolved; 1 patient with stn dbs for dystonia experienced surgery-related ins movement between 12 and 36 months after implant.This was noted to be ¿ongoing.¿; 1 patient with stn dbs for dystonia experienced a shocking sensation related to the device within 12 months of implant; this was noted to be resolved; 1 patient with subthalamic nucleus (stn) deep brain stimulation (dbs) for dystonia experienced surgery-related implantable neurostimulator (ins) movement within 12 months of implant.This was noted to be ¿ongoing.¿ the following device specifics were provided: lead model 3389; implantable neurostimulator kinetra model 7428; implantable neurostimulator activa pc model 37601.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6258779
• MDR Text Key: 65025898
• Report Number: 3007566237-2017-00167
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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,Followup
• Report Date: 01/17/2017

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: 01/04/2017
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: 01/04/2017
• Supplement Dates FDA Received: 09/28/2017
• 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): Other
• Patient Age: 49 YR