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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
Device Problem Failure to Deliver Energy
Event Date 07/27/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

 
Event Description

A consumer reported they had a problem where they were not aware their stimulation was off. For four days the patient was trying to walk and they could not. The patient contacted a health care provider (hcp) and they walked the patient through checking the implantable neurostimulator (ins) and they found the ins had been off for four days. The patient's indication for use is parkinson's dual. No interventions or outcome were 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.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information received from consumer indicated that patient's feet did not want to move and felt frozen. The patient was instructed by health care provider to turn the device on. As soon as they turned it back on, they were immediately able to move their feet.

 
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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 Key5024964
Report Number3004209178-2015-16572
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 08/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2011
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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