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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Date 11/10/2014
Event Type  Injury  
Event Description

It was reported the patient had experienced her hands trembling. The patient was reprogrammed on (b)(6) 2014 and reportedly her ¿symptoms got better after programming. ¿ then, five days prior to report, the ¿patient fell down because her legs were weak. ¿ the patient went to the hospital to be reprogrammed nine days after initial report as a result; however, the patient¿s physician ¿didn¿t do any parameter adjustments¿ at that time. The physician examined the patient and told the patient she ¿had brain stem and suggested to do programming after the brain stem was cured. ¿ the patient was hospitalized the following day ¿for treatment of brain stem. ¿ it was noted the patients legs ¿were still weak¿ at that time and that the physician ¿said the symptom was caused by brain stem. ¿ it was ¿unknown¿ whether the patient was receiving 50% or greater symptom reduction at that time. A supplemental report will be filed if additional information is received.

 
Event Description

Additional information stated the previously reported patient having "brain stem" referred to the patient having a "cerebral infarction. ".

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4).

 
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Brand NameACTIVA
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 Key4377420
Report Number3004209178-2015-00014
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/28/2015
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/04/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/12/2013
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: 01/02/2015 Patient Sequence Number: 1
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