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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRON IC NEUROMODULATION MEDTRONIC 2X4 POCKET ADAPTOR DEEP BRAIN STIMULATOR POCKET ADAPTER

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MEDTRON IC NEUROMODULATION MEDTRONIC 2X4 POCKET ADAPTOR DEEP BRAIN STIMULATOR POCKET ADAPTER Back to Search Results
Model Number 64002
Device Problem Appropriate Term/Code Not Available
Event Date 02/25/2016
Event Type  Injury  
Event Description

On (b)(6) 2016 pt had surgery to replace depleted dbs generator. On (b)(6) 2016 pt's essential tremors poorly controlled. On (b)(6) 2016 pt taken back to surgery to determine cause. Surgeon identifies pocket adapter as source of high impedance. Pocket adapter replaced. Old pocket adapter returned to manufacturer.

 
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Brand NameMEDTRONIC 2X4 POCKET ADAPTOR
Type of DeviceDEEP BRAIN STIMULATOR POCKET ADAPTER
Manufacturer (Section D)
MEDTRON IC NEUROMODULATION
minneapolis MN
MDR Report Key5906812
Report Number5906812
Device Sequence Number1
Product CodePJS
Report Source User Facility
Reporter Occupation
Report Date 08/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number64002
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/12/2016
Distributor Facility Aware Date02/25/2016
Event Location Hospital
Date Report TO Manufacturer08/12/2016
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/16/2016 Patient Sequence Number: 1
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