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

Model Number 37601

Device Problems Break (1069); High impedance (1291); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708695, serial#: (b)(4), implanted: (b)(6) 2021, product type: extension; product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3708695, serial/lot #: (b)(4), ubd: 10-jun-2025, udi#: (b)(4); product id: neu_unknown_lead, serial/lot #: unknown, ubd: 10-jun-2025.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the extension was implanted and showed high impedances.The problem did not occur when using another extension.The issue wasn't resolved and troubleshooting would be done on (b)(6) 2021.Additional information was received from the rep: it was reported that impedance measurements were run and showed out of range high impedances on the left side, and 15.8k ohms on the right.It was also reported that the extension was exchanged and impedances on the left side had not improved, so they suspected a defective electrode.

Manufacturer Narrative

Concomitant medical products: product id: 3708695, serial#: (b)(4), implanted: (b)(6) 2021, product type: extension; product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3708695, serial/lot #: (b)(4), ubd: 10-jun-2025, udi#: (b)(4); product id: neu_unknown_lead, serial/lot #: unknown, ubd: 10-jun-2025.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the extension was implanted and showed high impedances.The problem did not occur when using another extension.The issue wasn't resolved and troubleshooting would be done on (b)(6) 2021.Additional information was received from the rep: it was reported that impedance measurements were run and showed out of range high impedances on the left side, and 15.8k ohms on the right.It was also reported that the extension was exchanged and impedances on the left side had not improved, so they suspected a defective electrode.

Manufacturer Narrative

Continuation of d10: product id 3708695 lot# serial# (b)(6) implanted: 2021-(b)(6) explanted: product type extension product id 3708695 lot# serial# (b)(6) implanted: explanted: product type extension 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 extension was suspected to have a cable break with high impedances.The implant was switched off and the patient had no symptoms.They exchanged the extension, but the issue wasn't considered resolved.They stimulated via an adjacent contact and the patient was receiving benefits.

Manufacturer Narrative

Continuation of d10: product id 3708695, serial#(b)(6).Implanted: (b)(6) 2021.Product type extension product id 3708695, serial# (b)(6).Product type extension 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 electrode that was still implanted was believed to be damaged and causing the impedances.There wouldn't be any more actions/intervention to resolve the issue as stimulating the adjacent contact gave the patient benefit.

Manufacturer Narrative

Continuation of d10: product id 3708695, serial# (b)(6), implanted: (b)(6) 2021, product type extension product id 3708695, serial# (b)(6), product type extension product id 3389 lot# unknown, product type lead.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

Continuation of d10: product id 3708695 lot# serial# (b)(6) implanted: (b)(6) 2021 product type extension product id 3708695 serial# (b)(6) product type extension product id 3389 lot# unknown product type lead 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
• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13079375
• MDR Text Key: 285331199
• Report Number: 2182207-2021-02225
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2022

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 Date: 12/14/2022
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 01/20/2022; 02/01/2022; 04/27/2022
• Supplement Dates FDA Received: 01/05/2022; 01/31/2022; 02/07/2022; 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2021
• 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
• Patient Outcome(s): Required Intervention