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

Model Number 37612

Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 11/03/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2014, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 14-nov-2017, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 14-nov-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from 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 started feeling a shock sensation every two or three times she charges her ins (i.E.1 out of 2 or 1 out of 3 times charging).Caller states the patient says shock, which goes up her extension into her ear, only happens when 8 out of 8 coupling boxes are shaded in.They were asked what prompted this and stated the patient fell on (b)(6) but not on her head.Caller states electrode impedances looked good, then said they looked a little low but that low number was around 700.It was reviewed that short circuits should be quite lower.It was reviewed how to troubleshoot intermittent shorts, caller noted they may pursue an x-ray.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a rep stating the patient charged her ins at her appointment and did not experience the shocking sensation.The patient was referred for a neurosurgery consult and an x-ray to determine if there was a fracture in the extensions or lead.The fall was listed as a potential cause, however it was noted this was possibly unrelated.The shocking 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.

• 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: 8276273
• MDR Text Key: 134104730
• Report Number: 3004209178-2019-01699
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR