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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problems Electromagnetic Interference (1194); Vibration (1674); Electromagnetic Compatibility Problem (2927)
Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer who reported they had a ¿deep drone humming sensation/vibration and increasing dystonia symptoms in a new home; the deep brain stimulation (dbs) battery showed okay.The consumer stated there was a security system they never had with a magnetized ¿window¿ three feet from their bed, their son used wireless speaks/ipod in their old home with thick concrete walls while the new home had thin one.In addition, they just purchased a new scanning device and there was a garage door opening system they never had along with a second land line phone unit on their bed stand.The consumer was looking for assistance with what the problem might be or if they should look around the property to discover the issue or ask their neighbors about any radio transmission.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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 Key10385077
MDR Text Key202212748
Report Number3004209178-2020-13740
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169529786
UDI-Public00643169529786
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H020007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/10/2020
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 Date03/14/2017
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received08/10/2020
Date Device Manufactured09/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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