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

Model Number 37602

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Burning Sensation (2146); Twitching (2172); Cramp(s) (2193); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37602, serial#: (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.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 (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient is reporting pungent body odor and claims it is from dbs.Unknown if any environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/troubleshooting involved checking system.All impedances we re good and patient was receiving good therapy.Interventions/actions included system impedances taken and all were within range.It is unknown if the issue is resolved.All info was confirmed with the account.No surgical intervention occurred and none is planned.No further complications were reported or anticipated with this event.Additional information: it was reported that the patient reported a variety of symptoms such as body odor, burning sensations in their groin, and cramping that had been present for the past 10 years since their implant.They reported that for the past approximately 2 years they had been having stabbing pains in their back and shooting pains down the back of their leg, as well as transient twitching of their right pectoral muscle.The past month they reported 3 instances of their head jolting when they laid down for bed.The patient stated there were no falls or incidences.The patient was seen at the (b)(6) 2020.Their neurosurgeon and neurologists were made aware of the situation.They had a ct scan and the rep interrogated their device and ran an impedance test.Their physicians were informed of the results of the impedance test.The patient would be seeing their neurologist.The issue wasn¿t resolved at the time of the event.

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep stating the patient was not getting a shocking sensation.The cause of the head jolt, burning odor, and symptoms were unknown.Troubleshooting included the impedance test and the ct scan.He will see his neurologist to address further.

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 00777
• MDR Report Key: 9865460
• MDR Text Key: 184461523
• Report Number: 3004209178-2020-05914
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864207
• UDI-Public: 00643169864207
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• 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: 36 YR