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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 37612
Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)
Patient Problems Muscular Tics (2161); Complaint, Ill-Defined (2331); Tics/Tremor (4425); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/20/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 37751, serial#: unknown, product type: recharger.Product id: 37642, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer who reported about a month and a half ago they were near a metal detector at a courthouse and ever since they noticed their tourette¿s was ¿escalated,¿ the implantable neurostimulator (ins) battery was taking longer to charge, and the battery hadn¿t depleted in over a month.The consumer didn¿t walk through the metal detector but was under the impression the ins¿s proximity to the metal detector caused the ins to turn off.The consumer tried to check the ins with the patient programmer (pp), but the pp wouldn¿t power on even after the batteries were replaced with brand new regular alkaline batteries.According to the consumer it was possible the pp was dropped or got wet, but not likely.Due to current living conditions the consumer did not want the device replaced and was going to call back at a later time.The consumer used the recharger to start a charge session during the call and got all coupling boxes, but the it showed the ins was off.The ins was turned on and the consumer felt weird because the ins had been off for so long.The consumer stated they were okay and the feeling wasn¿t uncomfortable.The consumer was redirected to their healthcare provider (hcp) related to their symptoms.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key10800527
MDR Text Key221290924
Report Number3004209178-2020-19462
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000100360
UDI-Public00763000100360
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/01/2022
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 Date12/14/2020
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received06/01/2022
Supplement Dates FDA Received06/01/2022
Date Device Manufactured01/24/2020
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 Age29 YR
Patient SexFemale
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