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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 Problems Inappropriate Shock; Implant, reprogramming of
Event Type  Malfunction  
Event Description

It was reported that the patient experienced pain in their right hand when stimulation was on. The pain began following an accident. The patient also had a fused right thumb as a result of the accident. The patient turned off their stimulation and experienced a return of tremors. The patient has not undergone reprogramming as they had previously experienced a shocking sensation during programming. Additional information has been requested from the hcp, but was not available as of the date of this report.

 
Manufacturer Narrative

(b) (4).

 
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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 avenue
minneapolis , MN 55432-3576
7635263952
MDR Report Key1483535
Report Number3004209178-2009-05155
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 06/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/14/2008
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/27/2006
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: 07/27/2009 Patient Sequence Number: 1
Treatment
LEAD: MODEL 3387, LOT# J0206543V
IMPLANTED:
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXPLANTED:
EXPLANTED:
PROGRAMMER: MODEL 7438, LOT# NHL003419P
EXTENSION: MODEL 7482, LOT# NGK015707N
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