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

Model Number 37601

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Material Deformation (2976)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  Injury  

Event Description

Hold for em 3.9 it was reported that the patient had high impedances at their left stn lead.They also reported feeling a painless "zap" sensation over their ins that was new since (b)(6) 2020, and had twisted extension wires.The patient had surgical intervention on (b)(6) 2020 where the extension was explanted/replaced.The issue was unresolved with no further action planned.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# (b)(4), product type lead product id neu_unknown_ext, serial# unknown implanted: product type: extension other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 01-jun-2019, udi#: (b)(4) ; product id: neu_unknown_ext, serial/lot #: unknown, ubd: 01-jun-2019, udi#: if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 product type extension product id 3389s-40 lot# va18ynq 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 from the manufacturer representative (rep) reporting the exact cause of the high impedances at their left stn lead was not determined.It was reported that the patient had low impedances on left lead.After ipg and extension wires were replaced the high impedances became low impedances and it was determined the lead was the main issue.They checked impedances and found that impedances were low on contacts 1, 2, and 3 when used in a bipolar configuration.They tried disconnecting and reconnecting the left electrode to extension wire and extension wire to ipg connections however this issue remained.They therefore concluded that there was an issue with the left electrode itself.No further action taken.

• 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
• 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: 13713902
• MDR Text Key: 289503516
• Report Number: 3004209178-2022-03057
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Date Device Manufactured: 03/09/2016
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 118 KG