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

Model Number 37602

Device Problems Low impedance (2285); Battery Problem (2885)

Patient Problems Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); Weight Changes (2607); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) and a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for dystonia.It was reported that the patient's ins was replaced on (b)(6) 2019, and the rep stated the c/3 impedance at that time was 350 ohms.Now, the patient was programmed with c+3- and there was a short circuit: the impedance was 185 and 199 ohms; 16.5 ma.The ins battery was 2.88 v.Unipolar are fine 1600-1800 ohms.C+2-: 1696 ohms.Bipolar are fine 1700-1900 ohms.The patient settings were 3.5, 60us, 120hz.The rep indicated they do the automatic ramp when checking impedances which would likely test at a lower voltage, but this was noted as speculation.In the operating room, the rep tests impedances at 3v right away.The rep was concerned the battery was depleting more rapidly than would be expected.It was reviewed the battery curve does have an initial drop, but that the level of current output could shorten the ins longevity.No patient information was provided, but it was stated the therapy was still good.The rep was going to meet imminently with the patient and their managing nl.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Updated to adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient reporting that after the last battery replacement one of the leads started reporting the low impedances previously mentioned and the therapy is not as effective.The patient states when it was running on the lead program it was showing battery level of 2.8 volts and draining significantly but when it was changed to a different program the battery level was showing at 2.96.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep indicating the issue was repeating.Monopolar contact 3 was at 216 ohms.

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.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 received from a healthcare provider (hcp) indicated the therapy impedance is 190ohms with the following parameters, c+ 3- 3.5v 70 hz 120us 190ohms.The caller provided the following values: c 0 1844; 1 1664; 2 1693; 3 199; 1 0 2672; 2 3180; 3 1963; 1 2 2563; 3 1766; 2 3 1766.C+2- 1.2v therapy impedance 1447ohms and current 0.9ma.The battery voltage was 3.09v and at the last appointment it is at 2.88v.The patient had an appointment scheduled later in the week and the caller was sent an email to follow-up after the appointment.The impedance issue was still not resolved.

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.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

The caller followed up with the patient on the day of the call (b)(6) 2019 prior to an appointment scheduled for the afternoon.The caller reviewed the patient had been programmed on electrode 2 and 3 (instead of c and 3).The ins voltage displayed on the patient programmed had since increased since the therapy settings changed to 2.96v.The patient reported he had not been getting the same efficacy as he was 6 months prior.He had more foot drag and was gaining weight because he couldn¿t run.The caller also noted when the patient's child was a baby (the caller though that was a couple of years prior) he would kick or hit him in the chest.The caller noted that may have resulted in some potential damage to the device that was expressed when the ins was replaced.

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.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.

• 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 MN 00777 1200
• MDR Report Key: 8729503
• MDR Text Key: 150864032
• Report Number: 3007566237-2019-01367
• Device Sequence Number: 1
• Product Code: MRU
• 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,Followup
• Report Date: 11/10/2020

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: 02/28/2020
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 07/18/2019; 07/23/2019; 08/16/2019; 11/10/2020
• Supplement Dates FDA Received: 06/27/2019; 07/22/2019; 08/01/2019; 08/28/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR