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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 37603
Device Problems Battery Problem (2885); Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 08/01/2022
Event Type  Injury  
Manufacturer Narrative
Continuation of concomitant medical products: product id: 37603, serial#: (b)(4), implanted:: (b)(6) 2016, product type: implantable neurostimulator.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4).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
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The patient reported that the ins batteries were not working as well as they should.Agent asked the patient to clarify what they meant by that, and they said they were "not moving the right way," they could not move their legs, they were in so much pain, and their feet were killing them.Agent did not ask about the circumstances that led to the reported issue.The patient mentioned that they had an appointment with their doctor who told the patient that the ins batteries were getting low and will need to be replaced.The patient's reason for calling was to find out how to go about getting the ins batteries replaced.The patient was redirected to their healthcare provider (hcp) to further address the issue.Further troubleshooting was not performed because the patient insisted on ending the phone call due to them feeling like agent was of no help to them.The patient called back from 'phone 2' phone number and repeated information from call code notes regarding how they were in a lot of pain and were wondering how to get ins batteries replaced.Patient called back from secondary phone number asking to speak with rep.Patient services (pss) reviewed role of rep and redirected pt to hcp but let pt know that pss could send message to rep with pt's request.Pt repeated that they were due to have both implant batteries replaced (no allegations against longevity) and said that they were also probably going to have to have the leads replaced as well because there were some issues discovered a couple months ago with the leads because the leads had been hurting the patient and this had gotten worse.Pt asked what each implant battery level was at, pss offered to help check battery voltage with patient programmer and patient declined, pss again redirected pt to hcp.
 
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 received from the consumer reported the patients¿ batteries were getting low due to normal depletion.The consumer was scheduled for replacement in january but was going to get a second opinion.
 
Event Description
Additional information received from the manufacturer¿s representative (rep) reported they recommended the patient see their physician to discuss replacing the batteries if appropriate.
 
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 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 Key15810250
MDR Text Key303797925
Report Number3004209178-2022-15152
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00613994761071
UDI-Public00613994761071
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,Followup
Report Date 12/08/2022
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 Date11/28/2017
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/09/2022
Initial Date FDA Received11/16/2022
Supplement Dates Manufacturer Received11/16/2022
12/05/2022
Supplement Dates FDA Received11/18/2022
12/08/2022
Date Device Manufactured06/08/2016
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 Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexFemale
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