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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient had a throat issue since implant. During surgery or programming of the patient¿s implant in 2007 something happened and it had caused the patient¿s palate to not be able to close; it got the palate in his throat. As a result the patient could not talk and breathe at the same time. The patient could not speak well and could not be understood. The patient had 5 surgeries to fix the problem but it was not resolved. The 5 surgeries were on the patient¿s throat and now they were trying to help the patient with his speech but neither had worked. The patient¿s last surgery on (b)(6) prior to the date of this report a skin graft was used but that had not worked either. This was occurring daily. Reference manufacturer¿s report numbers: 6000153-2006-02427 and 2182207-2006-02428 for patient¿s previously implanted systems.

 
Manufacturer Narrative

Concomitant products: product id neu_unknown_lead, lot # unknown, implanted: (b)(6) 2005, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2010, product type implantable neurostimulator; product id 7426, serial # (b)(4), implanted: (b)(6) 2006, product type implantable neurostimulator; product id 3387s-40, lot # v012713, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension. (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 Key4934777
Report Number3004209178-2015-13938
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,COMPANY REPRESENTATIVE,CON
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/28/2011
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/02/2009
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: 07/23/2015 Patient Sequence Number: 1
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