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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 the device was implanted on (b)(6) 2013 and right after implant the patient lost functionality. The patient was able to walk with help but was not able to use his hands to eat, could not turn over in bed and could not move himself. The patient had physical and occupational therapy and had regained 30-40% of his functionality. The patient took a lot more sinemet orally. The issues had continued until the patient had a revision. Reference manufacturer¿s report number: 3004209178-2015-09174.

 
Manufacturer Narrative

Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead. (b)(4).

 
Manufacturer Narrative

(b)(4). Reference report number: mw5041381.

 
Event Description

It was later reported that the day following the patient's new implant his ability to function had taken a nose dive. The patient had been functioning extremely well, even driving a car with his previous device. Following the new device he felt very weak and ill for a day. The night following that day the patient had woken up unable to move much, he was extremely disabled. The patient's wife had to walk him to the bathroom, help him with his needs there and bath him. The patient's speech had worsened and he was unable to walk without help. The neurosurgeon was made aware and had stated that he could not explain how that would be related to the deep brain stimulator device. The patient was still functioning poorly but due to physical therapy he could walk with a walker and feed himself. The patient's change in function had basically been dramatically overnight and had taken a month of home healthcare to get the patient back to half the function he had before the new device. The patient had never returned to previous functioning levels.

 
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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
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4774612
Report Number3004209178-2015-09188
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2010
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/23/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/30/2008
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: 05/15/2015 Patient Sequence Number: 1
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