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

Model Number 37612

Device Problems Break (1069); Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Shelf Life Exceeded (1567); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Information was received from a healthcare professional regarding a patient who was implanted with a neurostimulator.It was reported since one week, the patient had felt periodic "electrical shooting" pain in the right arm, face, and neck.The feeling would stay in episodes of several seconds.No other symptoms were reported.There was no power loss and no "hypo-esthesia." it was indicated the patient had the feeling when he pushed on the stimulator pocket.He could "provocate" the electrical feeling.When the patient was in bed or at rest, the episodes of electrical feeling would disappear.Diagnostic methods included the patient reporting the issue (b)(6) 2017.Interrogation of the device occurred two days later and revealed ok impedances.Interventions involved reprogramming on the same day of impedance check where contact 2 was not used.The event had resulted in an emergency room visit and unscheduled clinic/office visit.Etiology was reported as possibly related to the device or therapy and unlikely related to the implant procedure.Other etiology was noted as contact 2 possibly being responsible for the feeling since the feeling would disappear when the contact was not being used.The outcome was resolved without sequelae (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported there were no other symptoms other than "electrical shooting" pain in the arm.Additional information received 5 days later reported the lead break was not confirmed.No complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 3389-28, serial# unknown, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the event was not related to the implant procedure.Other etiology was noted as possibly contact 2 on the lead.

Manufacturer Narrative

Concomitant medical products: product id 3389-28, serial# unknown, implanted: (b)(6) 2008m, product type lead.The device codes listed above are applicable upon further review.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported there was an additional device diagnosis that was not confirmed: lead fracture.No complications were reported/anticipated.

Manufacturer Narrative

The main component of the system, other applicable components are: product id: 3389-28, lot# b0762000k, implanted: (b)(6) 2008, product type: lead.(b)(4) applies to the lead.(b)(4) still applies to the ins.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the lead was suspected to have fractured.It was noted the lead was implanted in the left ventral intermediate (vim) nucleus.No further complications were reported/anticipated.

Manufacturer Narrative

Section d: in previous report, product information in section d and in h10 was updated with additional information to reflect updated and correct device details.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

Section d information references the main component of the system and other applicable components are: product id 3389-28 lot# b0762000k implanted: (b)(6) 2008 product type lead product id 748295 serial# (b)(6) product type extension product id 748295 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

It was reported the right extension was fractured and the patient was feeling off current/electrical shock.Since the last adjustments, the patient felt much more affected by the current thorough their body, particularly when they press on their skin near the ins site or during certain movements.When pressing on the skin, the impedance remains the same.A revision was performed and the extension was replaced on (b)(6) 2020.This event was considered related to the device or therapy, however, unrelated to the implant procedure.The issue resolved without sequelae on (b)(6) 2020.Additional information was received indicating a revision was performed on (b)(6) 2020, which did not confirm an extension fracture but it was assumed there was one.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6894416
• MDR Text Key: 88110707
• Report Number: 3002807576-2017-00069
• 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: foreign,health professional,s
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1