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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  Malfunction  
Event Description

Additional information received reported that the patient had been implanted bilaterally for essential tremor about 4 years prior to the date of this report. The patient had used them for a while and it had been recommended that he turn the device off at night to prolong the battery life. The patient had seemed to get very dizzy when it was turned off or turned back on again so about 3 years prior to the date of this report the patient had stopped using the device altogether to avoid the dizziness. The patient had very little tremor limitation in the meantime and had very good handwriting in particular. A couple of days prior to the date of this report his handwriting had worsened. The patient had wanted to turn the device on again but when he had gone to use the remote it had not worked. The 9-volt battery was probably dead. The patient was going to get a new battery and try again. More information was received and indicated that the patient did not have concerns with their device or therapy.

 
Manufacturer Narrative

Product id 7436, serial# (b)(4); product type programmer, patient product id 7 482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v479548, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v591417, implanted: 2010 (b)(6); product type lead. (b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id 7436, serial# (b)(4), product type: programmer, patient. Product id 7 482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id 3387s-40, lot# v591417, implanted: (b)(6) 2010, product type: lead. Product id 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description

It was reported that it had been a while since the patient had used the programmer and that they had never reviewed how to use it. There was a loss of therapeutic effect. Symptoms had a sudden onset about 2-3 days prior to the date of this report and he was not able to write because his hands had started shaking. There was no known accident or incident related to the complaint. The patient had gone to his healthcare professional and brought the programmer with him. The internal device was checked and he was told to start using the programmer again since he had not used it in a long time. It was noted that once he had given himself a treatment the shaking stopped. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

 
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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 Key4404816
Report Number3004209178-2015-00462
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/19/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/14/2011
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/16/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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