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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  
Manufacturer Narrative

Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. (b)(4).

 
Event Description

It was reported the patient was going to have a revision to remove the left ¿probe¿ next thursday. The lead is being removed because the patient lost all ability to swallow and speak and they had been on a feeding tube for eight months. The reporter stated the lead was not in the wrong spot, but it just was not where the patient¿s healthcare professional (hcp) put them. A new lead was to be implanted about a month after the lead was removed. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
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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 Key4802718
Report Number3004209178-2015-09853
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
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 Received05/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/28/2014
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/08/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/11/2013
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: 05/28/2015 Patient Sequence Number: 1
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