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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 the patient had a spasm on the left side implant. It was noted the patient had a lead revision due to capsular side effects. It was noted the patient status at the time of report was alive with no injury. It was further reported the patient outcome was unknown. Additional information received reported the cause of the event was a malpositioned lead. It was noted there were no abnormal impedance measurements. It was noted the patient had leg stiffness with the stimulation. It was stated after the lead was revised the patient had better tremor control and leg stiffness.

 
Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# v878980, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (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 Key3733828
Report Number3004209178-2014-05783
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/14/2013
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/17/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/15/2012
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: 04/08/2014 Patient Sequence Number: 1
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