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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) Back to Search Results
Model Number 37612
Event Type  Injury  
Event Description

It was reported that the patient had a globus pallidus lead hooked up the right clavicular rechargeable device and a subthalamic nucleus lead hooked up to the left clavicular primary cell device. The patient was seen due to routine programming. There was poor globus pallidus outcome. The globus pallidus therapy was turned off due to side effects. It was noted that the patient still needed to recharge if the device was off. It was noted that the subthalamic nucleus was fine with no issues. (b)(6) 2014 lfc (hcp): additional information received reported the cause of the event was a misplaced globus pallidus lead or right brain. The lead was not in target, the right globus pallidus was planned. Patient had a brain mri in (b)(6) 2013 that showed the lead on the right was misplaced. The subthalamic nucleus was reprogrammed to optimize therapy and globus pallidus was turned off, (b)(6) 2013. Signs and symptoms associated with the event were slurred speech, severe muscle spasms, imbalance, and swallowing problems. The patient had not required hospitalization. Patient outcome was serious injury/ illness, recovered without sequelae. The patient had bilateral subthalamic nucleus that were effective stimulation. Side effects resolved when turned off the right lead and reprogramming the subthalamic to optimize therapy results.

 
Manufacturer Narrative

Concomitant medical products: product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v297034, implanted: (b)(6) 2009, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v222841, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead. (b)(4).

 
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Brand NameACTIVA
Type of DeviceIMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
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 Key3690537
Report Number3004209178-2014-04735
Device Sequence Number1
Product CodeMRU
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/26/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/14/2013
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/26/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/20/2012
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: 03/20/2014 Patient Sequence Number: 1
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