MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Increased Sensitivity (2065); Burning Sensation (2146); Tingling (2171); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3387s-40, lot# v012545, implanted: (b)(6) 2007, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient with an implantable neurostimulator ( ins) for the treatment of dystonia and movement disorders.It was reported during a routine visit the patient complained of pain and sensitivity randomly and intermittently in both the chest area where the ins is located and also at different times where lead exits the head near the skull and/or above the ear.The pain in the head has been occurring for over a month and seemed to be increasing in strength so it woke her at night.The patient had an appointment scheduled for (b)(6) 2018 for follow up.The patient did not have a caregiver living.It was reported a scar from an unrelated procedure years ago was near/overlapping where her ins was located.It was unknown if any diagnostics or troubleshooting was performed.The doctor ordered and did x-rays but the results were unknown.The issue was not resolved at the time of the report.No surgical intervention occurred and it was unknown if it was planned.The patient was alive without injury at the time of the report.No further complications were reported or anticipated.Additional information was received from a manufacturer representative (rep).It was reported the patient was getting a tingling/shocking sensation at what they thought was likely the lead/extension connection.The caller was not with the patient so no troubleshooting could be done.On (b)(6) 2018 it was reported the patient mentioned that one of her dogs had jumped on her while lying in bed around the time she started to experience some pain.The dog landed near where the battery sat in the chest pocket.The patient reported the battery felt like it was sitting lower on her chest than before and it was observed that the incision scar was 1-2¿ above where the battery was located.Upon interrogating the battery they found there to be no impedance issues and the system checked out fine (within normal range) at.7 volts.The x-rays looked normal to the rep as far as they could tell as well.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported the cause of the tingling/shocking was not determined.The battery impedances all checked out fine and x-rays did not show any obvious breaks or disconnects in the wires.Because the discomfort had been intermittent, there was nothing done in the last office visit to change things up.It was unknown if the issue was resolved at the time of the report.No interventions were planned but the patient might consult the surgeon soon.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient stating it was confirmed the ins had shifted in their chest causing pain.They stated it may have been knocked loose and it was re-establishing new skin tissue.There was a burn and a lot of pain going on.

Manufacturer Narrative

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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7297349
• MDR Text Key: 101153386
• Report Number: 3004209178-2018-03984
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 65