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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO SOLETRA

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MEDTRONIC PUERTO RICO OPERATIONS CO SOLETRA Back to Search Results
Model Number 7426
Device Problem Inappropriate Shock
Event Date 02/01/2009
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The pt was shutting the back window of her car when she received a shock that traveled from her right hand, down her arm, across her chest, to her left arm. The pt was seen by her hcp. Impedances were normal. There was no power on reset. Therapeutic results were fine. Please see mfr. Report# 3004209178200901805. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

 
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Brand NameSOLETRA
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO
road #31 km 24 hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road #31 km 24 hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1344064
Report Number3004209178-2009-01804
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/13/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/28/2009
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/13/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2007
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: 03/13/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
LEAD: MODEL 3389S
LOT# NFW145594H
EXPLANTED:
LEAD: MODEL 3389S
EXPLANTED:
EXTENSION: MODEL 7482A
EXPLANTED:
PROGRAMMER: MODEL PROGRAMMER
IMPLANTABLE NEURO STIMULATOR: MODEL 7426
EXTENSION: MODEL 7482A
EXPLANTED:
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