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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL II

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MEDTRONIC NEUROMODULATION ITREL II Back to Search Results
Model Number 7424
Device Problem Loss of Power
Event Date 01/01/2009
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported the pt had an accident and was assaulted and was hit in the head with a broom. Since then, he had been unable to turn on his device and experienced intermittent right hand tremor. A rough longevity calculation was estimated and suspected the device is near end of life.

 
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Brand NameITREL II
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer Contact
charlotte gasperlin
7000 central ave.
minneapolis , MN 55432-3576
7635263952
MDR Report Key1325841
Report Number2182207-2009-01253
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7424
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/26/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
LEAD MODEL 3387 LOT# UNK
IMPLANTED:
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