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

Model Number 7428

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Inflammation (1932); Irritation (1941)

Event Type  Injury  

Event Description

Thrane, j.F., sunde, n.A., bergholt, b., rosendal, f.Increasing infection rate in multiple implanted pulse generator changes in movement disorder patients treated with deep brain stimulation.Stereotactic and functional neurosurgery.2014;92(6):360-364.Doi: 10.1159/000365576 summary: deep brain stimulation has been performed at the department of neurosurgery, aarhus university hospital (auh), for 16 years.The risk of infection related to implantable pulse generator (ipg) replacement constitutes a weakness in the long-term dbs treatment.The aim of this study is to investigate the association between risk of infection and number of ipg replacements.All patients who underwent ipg replacement at the auh from june 1996 until september 2012 were included in the study, and their medical records were systematically reviewed.The data was analyzed using fisher¿s exact test on contingency tables.220 procedures of ipg replacement were completed on 105 patients who suffered from various movement disorders.Up to 5 ipg changes were registered in a single patient.Thirteen patients incurred infection requiring surgical intervention.Testing for risk of infection associated with number of ipg changes, this study found significantly different infection rates (p = 0.0052).In the groups with 3 and 4 ipg changes, infection rates reached over 20%.This study found significantly different rates of infection related to the number of ipg changes.Further investigation and resources should be directed towards improving the lifespan of ipgs.Reported events: one 27-year-old male patient with deep brain stimulation (dbs) for dystonia experienced signs of chronic infection/inflammation with low virulent pathogen 12 weeks after an implantable neurostimulator (ins) replacement surgery.It was noted that the patient incurred a wound dehiscence and showed signs of an ongoing slow infection.This was dealt with initially, but the tissue irritation and implant rejection persisted.A culture of the wound was ¿negative x 2.¿ the patient was treated with bioclavid.Eighty-two days after the replacement surgery, the patient underwent debridement with gentacoll.One-hundred and four days after the replacement surgery, the patient had the ins replaced with a rechargeable model.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

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 patient information and additional information regarding the reported events.Concomitant products: product id neu_unknown_lead, lot# unknown, product type lead; product id neu_unknown_ext, lot# unknown, product type extension.(b)(4).

• Brand Name: KINETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4374383
• MDR Text Key: 5118991
• Report Number: 3007566237-2014-03828
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• 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: 00027 YR