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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Event Description

It was reported that after implantation of the stimulators, the patient¿s speech slowly began to worsen to the point where he was severely hypophonic and bradyphrenic at times when he attempted to speak. It was noted that over the prior few years, the patient had increasing stiffness and worsening posture and also had significant bradykinesia which increased when he walked. The patient underwent a revision of deep brain stimulation (dbs) leads a few years ago and at that time, it was noted that the leads dropped down the right side of his neck with the wires of both leads coming in contact with each other before they diverged into their respective generators in the bilateral chest.

 
Manufacturer Narrative

Product id 3389-40 lot# v005943, implanted: 2006 (b)(6); product type lead product id 3389-40, v005943, implanted: 2006 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2006 (b)(6); product type programmer, patient. (b)(4).

 
Manufacturer Narrative

The reported event does not pertain to the product line item previously reported. Refer to manufacturing report #¿s 3004209178-2013-20611 and 3004209178-2013-20613 for any additional information pertaining to this event.

 
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Brand NameKINETRA
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 Key3459430
Report Number3004209178-2013-20484
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2007
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/11/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/08/2006
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: 11/08/2013 Patient Sequence Number: 1
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