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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 37603
Event Type  Injury  
Event Description

It was reported that there was a left lead fracture adjacent to the stimloc. The action required as a result of the event was a replacement. Diagnostic testing and troubleshooting included impedance testing and x-rays. The issue was not resolved and the cause was not determined. Patient symptoms associated with the event were increasing dysphagia and rigidity in the left upper extremity. The location of the symptom was the lead location. 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 medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, implanted: (b)(6) 2013, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, 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 Key4565375
Report Number3004209178-2015-04048
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2014
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/10/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/24/2012
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: 03/03/2015 Patient Sequence Number: 1
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