MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Break (1069); High impedance (1291); Device Damaged by Another Device (2915); Impedance Problem (2950)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, udi#: asku.Product id: neu_unknown_lead, serial/lot #: unknown, udi#: asku.Product id: neu_unknown_ext, serial/lot #: unknown, udi#: asku.Product id: neu_unknown_ext, serial/lot #: unknown, udi#: asku.Country of event: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported there were out of range impedances the patient experienced minimal therapeutic benefit from deep brain stimulation ( dbs).The physicians planned to explant the leads and extensions, and keep the implantable neurostimulator (ins) inside for future re-implantation of the leads and extensions.

Event Description

Additional information was received.It was reported that the impedances were high, and that it was first observed during initial stage 2 dbs implant procedure.The suspected cause was overtightening of the screw on the lead cap used during stage 1 implant.There was no scheduled date for the explant procedure at the time of this report.

Manufacturer Narrative

Section d information references the main component of the system, other applicable components are: product id 3389-40 lot# 0217820931 serial# implanted: explanted: product type lead product id 3389-40 lot# 0218314943 serial# implanted: explanted: product type lead h6: device code c63114 no longer applies.C63124 has replaced it.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.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 d11: product id 3389-40 lot# 0217820931 serial# implanted: (b)(6) 2019 explanted: product type lead product id 3389-40 lot# 0218314943 serial# implanted: (b)(6)2019 explanted: product type lead product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2019 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.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 PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10632194
• MDR Text Key: 209960030
• Report Number: 2182207-2020-01014
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR