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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 3387-28
Event Date 04/09/2015
Event Type  Injury  
Event Description

It was reported that there was a subcortical hematoma on the frontal left lead trajectory during the procedure. Symptoms included dysarthria and language trouble at testing phase. It was unknown what had led to this event. Diagnostics included imaging with abnormal results of subcortical hematoma on frontal left lead trajectory. Interventions included interrupting the procedure. The left lead remained implanted and the right lead was not implanted. The issue was resolved. This was procedure related. The outcome was resolved without sequelae.

 
Manufacturer Narrative

Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
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 Key4957760
Report Number6000153-2015-00156
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/20/2018
Device MODEL Number3387-28
Device Catalogue Number3387-28
Device LOT Number0209237330
Was Device Available For Evaluation? No
Date Manufacturer Received07/10/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/20/2014
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: 07/31/2015 Patient Sequence Number: 1
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