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

Model Number 37601

Device Problems High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shaking/Tremors (2515); Electric Shock (2554)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3389-40, lot#: 0211587836, implanted: (b)(6) 2016, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 29-jun-2020, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 02-sep-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient went into the clinic for a follow up visit.They said their left body had worsening symptoms such as a wearing off with worse tremors.They felt electric shocks sometimes too.The patient stated that they fell down last month and believed to be a cause or contributing factor.The impedance measurements for their right stn had high impedances: monopolar - c<(>&<)>8 = 2711, c<(>&<)>9 = 3237, c<(>&<)>10 = 5174, c<(>&<)>11 = 10.2k.Bipolar -  8<(>&<)>10 = 4468, 8 <(>&<)>11= 9619, 9<(>&<)>11 = 8156, 10<(>&<)>11= 5368.Only some bipolar were ok such as 8<(>&<)>9=1995, 9<(>&<)>10=2711. however, the patient used monopolar 10 as setting; c+10-,amp4.5v, pw60, rate130.Therapy impedance showed high while current can¿t be determined.The physician decided to change their settings by using bipolar 9<(>&<)>10 that had a normal electrode impedance as below setting; 10-9+, amp5.0v, pw60, rate130 therapy impedance=2521 current=2.0 ma.The physician also adjusted the medications, but it was unknown if the issue was resolved.There was no surgical interventions that occurred.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3389-40 lot# 0211587836 implanted: (b)(6) 2016: product type lead product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 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 there were no plans for interventions.The patient had improved symptoms after their last programming and medication.However, some electrodes still had high impedances.Lt.Stn : ok rt.Stn : some electrode is high; c<(>&<)>8=2159, c<(>&<)>9=2829, c <(>&<)>10=3686, c<(>&<)>11=8840, 8<(>&<)>11=8791, 9<(>&<)>11=7891, 10<(>&<)>11=5489.Some electrode is ok; 8<(>&<)>9=1925, 8 <(>&<)>10=3597,9<(>&<)>10=2383.

• 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 00777
• MDR Report Key: 12343602
• MDR Text Key: 267307825
• Report Number: 3004209178-2021-12659
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 12/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1