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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 37603
Device Problems No Device Output (1435); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Ambulation Difficulties (2544)
Event Date 07/14/2020
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 and healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had shoulder surgery and came home, turned on the ins, and oor message appeared for the right implantable neurostimulator (ins).The inss were turned off for a few hours during the procedure.They were able to conference the wife on the phone and was able to bypass the oor screen and turn therapy on.The hcp asked if they should see the patient in clinic and was advised if oor occurs again.Additional information received from the consumer reported when they were unable to walk after surgery their spouse check their device found the oor code and they were unable to turn the device on.The consumer spoke with the healthcare provider¿s office who told them to push the arrow key to unlock the code allowing the device to turn on.No symptoms were reported.***see general text for omitted information***.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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.
 
Event Description
Additional information was received clarifying the oor message was seen with the patient programmer (pp) after the patient had surgery.The patient's wife was walked through interrogating the ins, which showed oor.They bypassed the oor message to normal therapy screen, which showed ins was off and the patient's wife then turned ins on.They mentioned the patient has an upcoming appointment with the hcp, possibly aug-13th.
 
Event Description
Additional information received from the consumer reported it was unknown what circumstances led to the oor.The patient was in surgery and the device wasn¿t turned off prior to.The healthcare provider (hcp) told the patient they were not exposed to any magnet or electromagnetic.The issue didn¿t resolve until the consumer spoke with the manufacturer¿s representative (rep) who told them to hold the controller on the battery and press the arrow key.After doing this the device turned off and was then restarted in the correct program.
 
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
MDR Report Key10391927
MDR Text Key202413486
Report Number3004209178-2020-13857
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169864214
UDI-Public00643169864214
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2019
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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