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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SOLETRA

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MEDTRONIC EUROPE SARL SOLETRA Back to Search Results
Model Number 7426
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2010
Event Type  Death  
Manufacturer Narrative

(b) (4): the implantable neurostimulator and extension have been returned to the manufacturer for analysis. A follow-up report will be sent when the analysis is completed.

 
Event Description

The patient expired. The cause of death was unknown and still under investigation. Additional information has been requested, a follow-up report will be sent if additional information becomes available. The patient had 2 implantable neurostimulators implanted (see also manufacturer's report # 9614453201002269).

 
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Brand NameSOLETRA
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route de molliau 31
tolochenaz
SWITZERLAND
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route de molliau 31
tolochenaz
SWITZERLAND
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1638609
Report Number9614453-2010-02270
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/14/2010
Device MODEL Number7426
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/09/2010
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/24/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/23/2009
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: 03/22/2010 Patient Sequence Number: 1
Treatment
LOT# NFW642444S
EXTENSION: MODEL 7482, LOT# NHU106166V
IMPLANTED:
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXPLANTED:
EXPLANTED:
IMPLANTABLE NEURO STIMULATOR: MODEL 7426
EXTENSION: MODEL 7482, LOT# NHU112220V
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