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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Injury  
Event Description

It was reported the parkinson's disease patient¿s implantable neurostimulator (ins) battery was found to have been depleted when checked in (b)(6) 2012. The ins was then replaced on (b)(6) 2012. The patient was reportedly told by their implanting doctor the ins could be used for eight years and they were wondering why it was ¿only used for about four years. ¿ it was ¿unknown¿ whether the battery depletion was considered normal. It was also noted the patient had experienced their hands shaking. Additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameSOLETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4471012
Report Number3004209178-2015-01519
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/14/2009
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/13/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/14/2007
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: 01/30/2015 Patient Sequence Number: 1
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