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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 Replace
Event Date 01/01/2009
Event Type  Injury  
Event Description

It was reported that the patient experienced a loss of therapeutic effect with return of symptoms (tremor of the right hand and arm). The patient was unable to adjust stimulation with their patient programmer or with one sent by loaner/repair. Patient commented on end of life of their implantable neurostimulator. Additional information received reported that the patient underwent a surgical revision of their implantable neurostimulator and was no longer experiencing stimulation problems.

 
Manufacturer Narrative

The patient programmer was returned for analysis/repair. The device tested according to specifications. There was no anomaly found. The implantable neurostimulator was not returned.

 
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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 Key1387040
Report Number3004209178-2009-03464
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/22/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/14/2008
Device MODEL Number7426
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/01/2009
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/22/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2006
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: 05/15/2009 Patient Sequence Number: 1
Treatment
IMPLANTED:
PROGRAMMER: MODEL 7438
EXPLANTED:
IMPLANTED:
PROGRAMMER: MODEL UNK
EXPLANTED:
EXTENSION: MODEL 7482
LEAD: MODEL 3387S
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