MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37603

Device Problems Disconnection (1171); High impedance (1291); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2022

Event Type  Injury  

Event Description

It was reported that the electrode in the patient's body is "buckled".No abnormalities were observed with impedance measurements.The patient's symptoms of this event observed to have a loss of treatment efficacy.For the purpose of investigation and improvement of the situation, on (b)(6) 2022, a replacement of the adapter/stimulator (ipg) was considered and the surgery was performed.When the hospital's own multimeter was connected via an alligator cable, the related lead, which was suspected to be disconnected, showed unstable condition and unstable impedance.Upon re-examining the fluoroscopic image, a figure that seems partially disconnected was observed.Once the lead was determined to be the issue, the surgery was discontinued midway.No devices were replaced.The cause of the lead disconnection was unknown.The physician suggested that the entire device will be removed and re-positioned in the future, however, the cause of the defect is not known and very uncertain.Background provided for the patient included using the rechargeable ipg since 2013, and there was a concern about the system sometimes as the patient experienced recurring symptoms even when the drugs were taken and stimulation was on.When they investigated using fluoroscopic imaging during implementation, it was confirmed that the area where the lead was coiled and looped was bent near the bur hole.Impedance check did not show any abnormalities during the long-term follow-up, but when the lead/extension connection region was incised during the operation and impedance was directly measured using the hospital's own multimeter, only the contact concerned was detected to have had an abnormal impedance value, such as a large change in impedance value.In the past as well, there have been many cases in which abnormal impedance were not detected despite suspicions of lead disconnection.Additional information was received that it is not determined yet if any actions/interventions will be taken.The cause is still unknown.

Manufacturer Narrative

Concomitant medical products: product id: 3389-28, lot#: 0207208661, implanted: (b)(6) 2013, product type: lead; product id: 3389-28, lot#: 0207250682, implanted: (b)(6) 2013, product type: lead; product id: 37603, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.Other relevant device(s) are: product id: 3389-28, serial/lot #: (b)(4), ubd: 19-jun-2017, udi#: (b)(4); product id: 3389-28, serial/lot #: (b)(4), ubd: 24-jun-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# 0207208661 serial# implanted: (b)(6) 2013 product type lead product id 3389-28 lot# 0207250682 serial# implanted: (b)(6) 2013 product type lead product id 37603 lot# serial# (b)(6) implanted: (b)(6) 2019 product type implantable neurostimulator.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 that it is not determined yet if any actions / interventions will be taken.The cause is still unknown.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# 0207208661 serial# implanted: (b)(6) 2013 explanted: product type lead product id 3389-28 lot# 0207250682 serial# implanted: (b)(6) 2013 explanted: product type lead product id 37603 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type implantable neurostimulator 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: it was reported that the method of electrode impedance testing described on p31 was introduced, but there was a comments that the contents of the inquiry couldn't be solved only by the contents described in the manual.On (b)(6) 2022 an ic for the same patient regarding the future operation response would be scheduled in-hospital conference and the physician would deal with the matter based on the product notification provided.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# 0207208661, (b)(6) 2013.Product type: lead.Product id 3389-28 lot# 0207250682.Implanted: (b)(6) 2013.Product type: lead.Product id 37603 serial# (b)(6), implanted: (b)(6) 2019.Product type: implantable neurostimulator.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: it was reported that the revision surgery was scheduled for (b)(6) 2022.The reported products are expected to be removed and returned.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# 0207208661 implanted: (b)(6) 2013 product type lead product id 3389-28 lot# 0207250682 implanted: (b)(6) 2013 product type lead product id 37603 serial# (b)(6) implanted: (b)(6) 2019 product type implantable neurostimulator.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: it was reported that nothing was removed during the revision on (b)(6) 2022.After the abnormalities were confirmed they closed the wound.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# 0207208661 implanted: (b)(6) 2013: product type lead product id 3389-28 lot# 0207250682 implanted: (b)(6) 2013: product type lead product id 37603 serial# (b)(6) implanted: (b)(6) 2019: product type implantable neurostimulator 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: it was reported that the leads were removed and replaced, but the physician was still determining to return the products.The cause of the unstable impedance seemed to be a disconnection.There were no abnormalities displayed in the impedance measurement using the programmer even though the damage to the lead could be seen visually.That was thought to be a problem as well.

• Brand Name: ACTIVA
• 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 Key: 14523087
• MDR Text Key: 292817767
• Report Number: 3004209178-2022-06873
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2022
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10....".
• Patient Outcome(s): Required Intervention
• Patient Sex: Male