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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 Date 12/10/2014
Event Type  Malfunction  
Event Description

It was reported the patient had a loss of therapeutic effect. The patient had the implantable neurostimulator (ins) in their upper left chest for the right side of their body. For the last couple of days the patient¿s right arm had been shaking. The reporter stated the implant near the right collar bone did not work because it was in the wrong spot in the patient¿s brain so it did not work. It had not worked for a while so it was not on. The reporter stated they put it in the wrong spot in the brain. The ins was on and there was no known accident or incident related to this complaint. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

 
Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # va08kln, 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 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead. (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 Key4377933
Report Number3004209178-2015-00065
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/12/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2014
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Date Manufacturer Received12/12/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/24/2013
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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