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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ACTIVA RC NEUROSTIMULATOR
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MEDTRONIC ACTIVA RC NEUROSTIMULATOR Back to Search Results
Device Problems Break (1069); Material Rupture (1546)
Patient Problems Failure of Implant (1924); Pain (1994); Skin Erosion (2075)
Event Date 05/04/2017
Event Type  Injury  
Event Description
My implanted medtronic dbs device had a serious and potentially life threatening malfunction on (b)(6) 2017.That morning, i noticed that the wires running between the leads implanted in the brain and the rechargeable battery (located in my abdomen) had ruptured/broken through their routing in my neck, being exposed visibly and painful.I called my surgeon, dr.(b)(6), who saw me that afternoon, who told me that i needed immediate, emergency surgery to prevent further decay in my skin (neck area) as well as prevent an infection in my head (brain).This is the second time i've had an adverse event with the medtronic rechargeable dbs unit.Needless to say i had emergency surgery the following morning, (b)(6), and am recovering well.Again, this cost me an unplanned and unanticipated $(b)(6) (2nd time in 14 months).Per my surgeon, this was an ae, and he's never seen this before, after implanting over 400+ "dbs systems" over the past 10+ years.
 
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Brand Name
ACTIVA RC NEUROSTIMULATOR
Type of Device
NEUROSTIMULATOR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6614164
MDR Text Key76857369
Report NumberMW5070176
Device Sequence Number1
Product Code MRU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/01/2017
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/01/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age45 YR
Patient Weight62
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