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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 37601
Event Date 07/03/2013
Event Type  Injury  
Event Description

It was reported the patient had a syncopal episode that was originally noted as no relation. Additional information indicated it was unknown if the syncopal episode was related to the study or programming. In-patient hospitalization was required due to the event and levetiracetam was given as an intervention. The event was considered resolved.

 
Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # va04z6f, implanted: (b)(6) 2013, product type lead; product id 3708660, lot # nkn045745v, implanted: (b)(6) 2013, product type extension; product id 3708660, lot # nkn045747v, 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 Key4898563
Report Number3004209178-2015-12945
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2013
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Date Manufacturer Received06/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/18/2012
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: 07/08/2015 Patient Sequence Number: 1
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