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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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IPG MFG SWITZERLAND ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cognitive Changes (2551)
Event Date 08/15/2013
Event Type  Injury  
Event Description
It was reported that the patient had delusions with jealousness.The patient had psychotic symptoms and was admitted to psychiatric hospital.The outcome was resolved with sequelae.Further follow up is being conducted, if additional information is received, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH  1131
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 Key4712747
MDR Text Key19637617
Report Number9614453-2015-01008
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/14/2012
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2015
Date Device Manufactured05/26/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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