MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number	37602
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that manufacturer representative (rep) called today to ask further questions regarding options for issue with high impedances on contact 0 that can't be resolved.Caller indicated he is not at the case but is assisting the reps at the case.They changed out the old style (duckbill) extension for new extension to convert patient to new ins.Upon testing with new extension, contact 0 is showing high.Total of 3 extensions tried with ins and contact 0 still showed high, lead was wiped down.Lead tested fine in operating room, impedances tested fine prior to removing the previous ins.No patient information was available at the time of this call.No symptoms were reported.Additional information was received.It was reported that there were normal impedance pre-operation.The new extension and percept had high impedances (over 5k mono and 10k all bipole).Reconnected and changed ports with no change.Twist lock on lead had normal impedance.The second percept had high impedance.The 37603 had high impedance.Total of 3 extensions used showed high impedance.Normal impedances only occurred when the hcp ran saline over the lead/extension connection.The lead was not active so percept with the 3rd extension were implanted with the impedances slowly decreasing in post-op but still high.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 03-jun-2025, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 17-jun-2025, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 07-sep-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Continuation of d10: product id 37603 lot# serial# (b)(6) implanted: explanted: product type implantable neurostimulator product id 3708660 lot# serial# (b)(6)implanted: explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension product id b35200 lot# serial# (b)(6)implanted: explanted: product type implantable neurostimulator product id 3708660 lot# serial# (b)(6) implanted: 2022-(b)(6) explanted: product type extension product id b35200 lot# serial# (b)(6) implanted: 2022-(b)(6) explanted: product type implantable neurostimulator b5: new information 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 or Problem Description
Additional information was received from the rep clarifying that the original replacement of the 37602 and extension was hcp replaced extensions at time of battery replacement to allow for full body mri.No issues prior and impedances were normal prior to replacement.The cause of high impedance is unknown.Impedance still high but dropping in recovery room.No issue with therapy but hcp concerned patient will be unable to have full body mri which is was why he changed extension.Pt to be interrogated at post operation appointment (b)(6) 2022 to determine if change to impedance values.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep) reported at the patient¿s post-operative appointment on april 5th there were no changes in impedances on 4/5.
Additional 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.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 13955517
• Report Number: 3004209178-2022-04020
• Device Sequence Number: 4272036
• Product Code: PJS
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/27/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/06/2022; 04/28/2022
• Date Device Manufactured: 12/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 65 YR
• Patient Sex: Male