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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 PARKINS
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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37612
Device Problems Failure to Deliver Energy (1211); Unstable (1667); Battery Problem (2885)
Patient Problem Shaking/Tremors (2515)
Event Date 06/16/2021
Event Type  malfunction  
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
It was reported that the recharger will lose connection after 2-5 minutes of charging.Rep noted calling pt about 1.5 weeks ago to train for initial charger use.During that call there was no issue, however rep was only on the line for the first minute or 2 of charging.Rep was notified yesterday that pt has been unable to charge since, the recharger loses connection after about 4 minutes and service code 575 has displayed, pt ins drained to zero, therapy turned off and pt was tremoring.Phone troubleshooting did not resolve so rep met pt in person yesterday and noted that sometimes even after 2 minutes the charger lost connection.During the call pss reviewed how to reset the recharger.This appeared to resolve the reported issue and caller charged pt the remainder of the call (5+ minutes).The troubleshooting steps that were taken on the call resolved the issue.The cause was unknown but after a reset, the device was working as intended.The patient (pt) reported that the wireless recharger (wr) continues to have issues charging the ins.Wr will connect with ins briefly but then will loose connection after a couple seconds.Patient services (pss) had pt hard reset wr but issue continued on call.Pt said that issue started when they got the ins but had just become worse and worse to where they would have to charge the ins all day.The pt said that the ins stuck out and didn't lay flat, part of the ins corner was sticking out more than the rest of the ins.Pt mentioned they saw their hcp in march but hadn't mentioned issue to dr.Yet.Pt is seeing hcp in june and will mention issue to hcp then.Pt mentioned they have device for pd and said the pd made their voice hard to hear over the phone.Pss reviewed if replacement doesn't resolve issue, hcp would need to address ins charging issues.
 
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 from the consumer who reported that the circumstances that led to the implantable neurostimulator (ins) being stuck out and didn't lay flat was due to the way in which the surgeon placed it.The steps taken to resolve the issue were the patient is laying the charging unit differently.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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 Key14695953
MDR Text Key301571221
Report Number3004209178-2022-07640
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000384357
UDI-Public00763000384357
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2022
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2021
Date Device Manufactured05/11/2021
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 Age70 YR
Patient SexFemale
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