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

Model Number 37603

Device Problems Break (1069); Low impedance (2285)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: implantable neurostimulator.Product id :3708660, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: extension, product id: 3708660, serial#: (b)(4).Implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 01-jul-2017, implanted: (b)(6) 2014, explanted: (b)(6) 2021, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 14-nov-2020, implanted: (b)(6) 2018, explanted: (b)(6) 2021, udi#: (b)(4).Additional review indicates that information from manufacturers report #3004209178-2021-04830 was already reported in this report.Any additional information regarding that event will be submitted as a supplemental.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins) for dystonia.It was reported that the patient had a short on pair 2 & 3.The cause was unknown, however the patient was not currently programmed to these contacts.The issue was unresolved with no further action planned.The etiology was noted as related to the device/therapy and not related to the implant procedure.No further complications were reported as a result of this event.Diagnostics included imaging the results of which were normal for head, neck and chest as of (b)(6) 2018.Additional information was received indicating the outcome was ongoing and therapy has been suspended with an action date of (b)(6) 2019.The patient reported an increase in cervical dystonia symptoms.The plan is to monitor clinical effect with therapy suspended and then remap lead avoiding these contact.It was determined with trial of suspended stimulation that the patient's dystonia was worse with their dbs off, but still maybe worse compared to baseline before low impedance.The patient was reprogrammed on (b)(6) 2019 and was reprogrammed on (b)(6) 2020.As of (b)(6) 2020, the low impedance was now involving 0 & 3 pair.The physician stated that consistent impairment at contact 3 would be monitored.Additional information was received indicating therapy was suspended again on (b)(6) 2020, and was previously reprogrammed on (b)(6) 2019.Therapy was later resumed; however, additional information received indicated that the leads, extensions and ins were explanted and replaced.Additional information indicated that the leads were broken.The patient was reprogrammed on the same day as ins replacement.The extensions and inses were explanted in order to place a dual channel battery at a later date.The replacement resolved the issue.Refer to manufacturer report #3004209178-2019-05071 for details pertaining to the reportable related event.

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 indicating the lead was explanted/replaced on (b)(6)2021 and the extension was explanted/not re placed on 2021-mar-17.The ins was explanted/not replaced on (b)(6) 2021.

Event Description

Additional information clarified that the leads were not broken; they were just shorted.

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.

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 indicating the issue resolved without sequelae on (b)(6) 2021.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11860201
• MDR Text Key: 265174825
• Report Number: 3004209178-2021-08076
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2021

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 Date: 08/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 05/21/2021; 05/29/2021; 05/21/2021
• Supplement Dates FDA Received: 05/25/2021; 06/02/2021; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR