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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  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a week prior to the date of this report, the patient had a hard time moving his legs and arms. The patient was currently bedridden and unable to move. The patient would like to have the device reprogrammed. It was noted that the patient was currently hospitalized. It was later reported that the patient outcome was unknown. It was suggested that the patient to have programming done in the hospital but the result was unknown.

 
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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 Key3447058
Report Number3004209178-2013-20126
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/14/2012
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Date Manufacturer Received02/17/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/26/2010
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: 11/04/2013 Patient Sequence Number: 1
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