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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO., JUNCOS KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MDT PUERTO RICO OPERATIONS CO., JUNCOS KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Device Problem Inappropriate Shock
Event Date 08/30/2010
Event Type  Injury  
Event Description

It was reported that the pt experienced stimulation in the wrong location. While the device was on, the pt could not use her left hand due to the placement of the lead. The other lead was ok but not optimal. Additional information has been requested and will be made as f/u as it becomes available.

 
Event Description

Additional information received reported that the patient did not have good results originally. It was noted that the right brain lead was replaced because the original placement was not giving her tremor control on the left hand. Additional information was requested but was not available as of the date of this report.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Concomitant: product id 3387s-40, lot# v007141, implanted: (b)(6) 2006, product type lead; product id 3387s-40, lot# v007141, implanted: (b)(6) 2006, product type lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

 
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Brand NameKINETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO., JUNCOS
road #31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
road #31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777 554
Manufacturer Contact
chad hedlund
7000 central ave ne
rcw215
minneapolis , MN 55432-3568
7635149619
MDR Report Key1850877
Report Number3004209178-2010-07400
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Type of Report Initial,Followup,Followup
Report Date 08/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/28/2010
Device MODEL Number7428
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received11/21/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2009
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: 09/28/2010 Patient Sequence Number: 1
Treatment
EXPLANTED:
EXTENSION: MODEL 7482, LOT# NHU132313V
IMPLANTED:
LEAD: MODEL 3387S, LOT# V007141
IMPLANTED:
EXTENSION: MODEL 7482, LOT# NHU132312V
EXPLANTED:
EXPLANTED:
EXPLANTED:
IMPLANTED:
LEAD: MODEL 3387S, LOT# V007141
IMPLANTED:
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