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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Muscle Weakness (1967); Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Event Description
It was reported there was a loss of therapeutic effect.The patient was falling.He used to fall before having the implantable neurostimulator (ins) but now he was starting to fall again.They fell 2-3 times two days prior to report and went to the er at midnight.The patient fell again several times the day prior to report and went to the er again at 10pm.While the patient was in the er they had a ct scan on the head.The ct scan that was done in the emergency room was negative.He also fell several times while on vacation for 2 months in (b)(6) 2015.The patient was trying to walk and he had been freezing in his legs.They had told him to move his legs and he couldn¿t.It was noted that this was something the patient had previously to the ins.The falls had been getting worse and because of the falls, he had torn his left shoulder out of the pocket and he has to get his left shoulder fixed.His legs were deteriorating and he doesn¿t have strength in his legs.Additional information received 3 days later reported there was not a 50% or greater symptom reduction.The cause of the event was not determined and it was unknown if it was device related.It was unknown if reprogramming was needed.The patient wondered if a ¿wire came loose with falls.¿ the patient was going to be hospitalized on (b)(6) 2015 and they would check for wire fracture.They would have an upcoming admission to the hospital for medication adjustment.The patient had not yet recovered and they were in physical therapy.
 
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v333260, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v276341, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37642, serial # (b)(4), product type programmer, patient.(b)(4).
 
Event Description
Additional information received reported that the patient was admitted at the hospital and the therapy was reviewed.There were no lead issues noted, no lead fractures, or loose wires due to the falls.The patient's medications were adjusted and they were continuing to monitor medications at the time of report.The therapy was working as designed and there were no malfunctions noted.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, 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 Key4898863
MDR Text Key6829671
Report Number3004209178-2015-12963
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 06/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/28/2014
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/08/2015
Initial Date FDA Received07/08/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/23/2015
Date Device Manufactured05/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age00068 YR
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