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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

Concomitant products: product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3387-40, serial # (b)(4), implanted: (b)(6) 2012, product type lead; product id 3387-40, serial # unknown, implanted: (b)(6) 2012, product type lead. (b)(4).

 
Event Description

It was reported the patient had two new leads implanted on (b)(6) 2012 because the target of the patient¿s initial two leads ¿was not accurate. ¿ because the patient had ¿brain edema¿ at the time however, the initial two leads ¿were not explanted¿ at the time of implant of the two new leads. While the patient had ¿spoken normally¿ following the initial implant of their device system in (b)(6) 2011, the patient ¿couldn¿t speak¿ after the 2012 implant procedure. The patient¿s doctor reportedly ¿said the symptom was caused by brain edema. ¿ the patient was ¿anxious¿ and she ¿spoke unclearly¿ at the time of report, however ¿she had no trembling and rigidity problem¿ at that time. It was noted the patient¿s implantable neurostimulator ¿battery was low¿ at the time of report and remained implanted. It was ¿unknown¿ whether any troubleshooting had been performed or what the patient¿s outcome was following the report. Additional information has been requested. A supplemental report will be filed if additional information is received.

 
Event Description

Additional information reported the cause of the brain edema was "unknown" at the time of follow-up. It was noted the edema was reportedly "not related with product quality" and that it "had some relevance with therapy, but was not directly related. ".

 
Manufacturer Narrative

 
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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 Key4174577
Report Number3004209178-2014-19750
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/14/2012
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/11/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/25/2011
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: 10/15/2014 Patient Sequence Number: 1
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