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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 37612
Event Type  Injury  
Event Description

It was reported that the patient had a change in mental status. The patient had gone crazy; patient was paranoid, acted schizophrenic, irrational, was jumping out of moving vehicles on the highway and was running around in traffic on the highway. Since march prior to the date of this report the patient had been in a psychiatric system 5 times without seeing a healthcare professional and had gone to another psych unit for a 4 day period which was the longest one and had not seen a healthcare professional. The patient was in jail at the time of this report as he had been deemed a danger to himself and others. The patient was currently on cinemas and had been previously been on forms of requip. Over time the patient had gone from 20mg to 3mg of medications due to the mental effects. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (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 Key4805324
Report Number3004209178-2015-09928
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 05/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2010
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Date Manufacturer Received05/08/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/02/2009
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: 05/29/2015 Patient Sequence Number: 1
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