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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
Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Muscle Spasm(s) (1966); Electric Shock (2554)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an implantable neurostimulator (ins) replacement the patient experienced a sudden shocking sensation with heavy muscular contraction on the right side of the body from head to toes, including heavy contraction or right corner of mouth/cheek, and the patient was unable to speak normally for approximately 4-5 minutes after the event.The patient did not feel any pain or heat during the contraction or afterwards.The pocket was not fully open at the time of the shocking, and the surgeon noted they could not see the ins or extension at that time.The surgeon was using a radiofrequency electrosurgical instrument at the time of the event, and the event occurred while the old (almost depleted) ins was still connected to the system.The ins was not turned off prior to the procedure.A patient return electrode was placed on the patient's right upper thigh top.The electrosurgical smoke evacuator and remote switch activator were not in use at the time of the event.It was also noted the surgery took place with patient awake using local anesthetic.The replacement was completed with closure of the battery pocket.After about 5 minutes, the patient felt normal again, and no burning was detected around the ins pocket, nor along extension or lead paths.Impedance check confirmed impedances were in normal range.The patient was implanted for parkinson's disease.
 
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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
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10622609
MDR Text Key209976952
Report Number3004209178-2020-17166
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/02/2020
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? Yes
Device Operator Health Professional
Device Expiration Date07/14/2013
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/17/2020
Initial Date FDA Received10/02/2020
Date Device Manufactured01/26/2012
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 Age72 YR
Patient Weight90
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