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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Injury  
Manufacturer Narrative

Product id 3387s-40, v515921, implanted: 2010 (b)(6); product type lead product id 3387s-40, v515921, implanted: 2010 (b)(6); product type lead product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).

 
Event Description

It was reported that with stimulation turned on images were distorted during a sleep study. Patient was having trouble swallowing and speaking. Sometimes her speech was very clear but as the day went on she gets tired and her voice gets softer and she couldn¿t annunciate. Patient did not have these issues before implantation. Issues started at the (b)(6) 2013. Patient¿s health care professional has not been able to make adjustments to help her speaking and swallowing issues. Speaking issues will come and go. The patient will be good for 1-1. 5 months after an adjustment and then their speech and swallowing issue would return. Patient had to eat very slowly. Patient had a barium swallow study done which showed food goes into her lungs. Patient could only eat food with a pudding like consistency. Patient said, she fell and continued to fall because she had balance problems. Adjustments to stimulation had been made to stop the falling issue. Falling issue had been fixed. Patient¿s health care professional wanted to do an mri to look at her device or therapy.

 
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Brand NameACTIVA
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
chad hedlund
7000 central avenue ne rcw215
minneapolis , MN 55432
7635149619
MDR Report Key3456405
Report Number3004209178-2013-20400
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/28/2013
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/17/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/07/2012
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: 11/07/2013 Patient Sequence Number: 1
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