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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 Failure to Read Input Signal
Event Date 09/25/2009
Event Type  Injury  
Event Description

The pt visited the hospital and their battery status showed 3. 7 or 3. 8v. One week later the pt re-visited the hospital with shaking hands. It was impossible to take telemetry. The pt's device was explanted.

 
Manufacturer Narrative

Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

 
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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 du molliau 31
tolochenaz
SWITZERLAND
Manufacturer Contact
charlotte gasperlin
7000 central avenue
minneapolis , MN 55432-3576
7635263952
MDR Report Key1545798
Report Number9614453-2009-08537
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/22/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/14/2008
Device MODEL Number7426
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/09/2009
Is The Reporter A Health Professional? Yes
Device Age28 mo
Event Location Other
Date Manufacturer Received10/22/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/19/2006
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: 11/18/2009 Patient Sequence Number: 1
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