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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Date 03/14/2015
Event Type  Injury  
Event Description

It was reported that the patient had acute delirium. Signs and symptoms included verbal agitation, confusion, encephalopathy and slight seizure activity. It was noted that the surgery/anesthesia was possibly related to the device or therapy and it was possibly related to implant procedure. The event had resulted in in-patient hospitalization and seizure medication. Lab work results were negative for an infection. Electroencephalogram (eeg) results indicated no seizure, no rhythmic or periodic patterns, intermittent bursts of generalized delta activity with slow posterior dominant rhythm (pdr). A computerized tomography (ct) scan without contrast results indicated edema in the superior right frontal lobe. The outcome was resolved without sequelae.

 
Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). (b)(6).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key4771432
Report Number3004209178-2015-09096
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/24/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/04/2014
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: 05/14/2015 Patient Sequence Number: 1
Treatment
"SEE H10...."
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