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

Model Number 37612

Device Problems Unstable (1667); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia and deep brain stimulation (dbs) therapy indications.It was reported that it was taking too long to charge and they were experiencing poor coupling.They recently only were able to get 0,2, or 4 coupling bars and she has been charging for the past hour and a half.The patient states she usually gets 8 coupling bars band it charges in 15 minutes.The patient states this has happened before but it usually resolves itself.The patient says she turns the antenna dial and still does not get coupling bars.Troubleshooting involved repositioning the antenna over the ins.They tried this with no improvement.No out of box failure was reported.No symptoms were reported.A replacement antenna was sent to the patient.Additional information was received from a manufacturer representative (rep).The rep stated that they had tried 3 different ins rechargers (insrs) and the patient's new antenna and could not get more than 2 bars.It was stated that the ins is superficial , they can grip both sides, there is no edema and it is just skin over the ins.The caller reviewed they were getting about a 20 point difference between the minimum and average numbers of the al-with several different insrs.Patient reported no falls/trauma, impedances are fine and coupling issue started suddenly.Caller stated that the patient had been sent to for x-rays and questioned what if the issue is that the ins is not flipped.It was reviewed for the caller that if the ins is not flipped , then the issue is not with the external equipment, but the only factor left is the ins.It was reviewed for the caller to see what the x-rays show and proceed from there.

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the poor coupling was not determined, but an x-ray had shown the ins flipped sideways.The hcp used their fingers to twist the battery back into place.The poor coupling had been resolved.The patient also noted that they would wear kinesiology tape and wear a sports bra at night through the end of march per the surgeon.There were no further complications reported.

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: 8417832
• MDR Text Key: 138795372
• Report Number: 3004209178-2019-05193
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR