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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 37602
Event Type  Injury  
Event Description

Additional information received reported the cause of the event was too much voltage. It was noted there were no abnormal impedance measurements. It was noted reprogramming was performed 19 days prior to report. It was stated the patient did not require hospitalization and there was no injury or illness and the patient recovered without sequelae. It was noted the patient seldom operated the deep brain stimulator (dbs) as they did not want to waste the battery.

 
Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead. Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Event Description

It was reported there was a shocking or jolting sensation. It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report. It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant. It was noted the patient had fallen on (b)(6) 2013. It was stated they had fallen and broken their hip. It was noted the patient had not done well since the fall. It was noted the paralyzed feeling in their leg had not gone away. It was stated their arm would go paralyzed for 8 seconds and then it would stop. It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings. It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.

 
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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 Key3734588
Report Number3004209178-2014-05812
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2014
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 Date09/28/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/21/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/04/2012
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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