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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; DEEP BRAIN STIMULATOR (DBS)
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MEDTRONIC MEDTRONIC; DEEP BRAIN STIMULATOR (DBS) Back to Search Results
Model Number ACTIVA RC 37612
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 10/27/2014
Event Type  Injury  
Event Description
Lead fracture left.Family noticed increased dystonic movements at home and at school.Interrogation of dbs in office on (b)(6) 2014 showed high impedances and low therapeutic current delivered by the left brain stimulator.X-rays of head, neck, and chest were ordered to investigate lead fracture.Appointment made to see dr (b)(6) in three days.X-rays confirmed left electrode has fractured.Saw dr (b)(6) on (b)(6) 2014 to discuss options.No palpable fracture of dbs lead.No tenderness.The plan was discussed and decided upon, to replace the left dbs lead.Scheduling surgery date.
 
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Brand Name
MEDTRONIC
Type of Device
DEEP BRAIN STIMULATOR (DBS)
Manufacturer (Section D)
MEDTRONIC
minneapolis MN
MDR Report Key4284255
MDR Text Key5225641
Report Number4284255
Device Sequence Number1
Product Code GYZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberACTIVA RC 37612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2014
Distributor Facility Aware Date10/30/2014
Event Location Home
Date Report to Manufacturer11/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TRILEPTAL; TRIHEXYPHENIDYL,
Patient Outcome(s) Required Intervention;
Patient Age15 YR
Patient Weight27
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