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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MDT SOFAMOR DANEK PUERTO RICO MFG SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id 3387-40, lot# j0322214v, implanted: (b)(6) 2003, product type: lead. Product id 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 37642, serial# (b)(4), product type: programmer, patient. Product id 3387-40, lot# j0327188v, implanted: (b)(6) 2003, product type: lead. Product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 64002, lot# n274415, implanted: (b)(6) 2011, product type: adapter. Product id 37092, lot# 276480001, implanted: (b)(6) 2011, product type: accessory. (b)(4).

 
Event Description

The consumer reported that over the past five years the patient had experienced sudden "bouts" of dementia and that each time they experienced these symptoms they had been given antibiotics, which seemed to take care of the symptoms. The last time this happened, however, the antibiotics did not take care of the patient's symptoms, and the patient's family was wondering if the symptoms could be a result of an undetected infection with one of the components. It was noted that the patient fell a lot and did not seem to have impulse control, which is when they would have a fall. No outcome or diagnostics were provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indications for use: parkinsons dual movement disorders refer to manufacturer report # 3004209178-2015-16415.

 
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Brand NameSOLETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
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 Key5019305
Report Number6000032-2015-00149
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2004
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 Received07/27/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/04/2003
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: 08/20/2015 Patient Sequence Number: 1
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