MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/01/2018

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 via a manufacturing representative about a patient with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was implanted two weeks prior with their ins.The patient's programmer showed an out of regulation error.The patient was able to bypass the message.The ins status was on and okay message, with the battery level at 2.97 v.The system impedance was not known.There were no symptoms reported.No further complications were reported or anticipated.It was reported that the patient tried to adjust their stimulation by.1v on (b)(6), and received the oor message again.

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 patient received the oor message again.The previous suggestions for resolving the issue did not work.

Event Description

Additional information was received.There were no additional actions, troubleshooting, or diagnostics planned related to the oor issue at the time of this report.The physician was still attempting to find good program settings in monopolar stimulation.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) via the manufacturer representative (rep).Oor had been ongoing since 2 weeks after implant.The patient has visited the clinic and the oor message was still appearing.Impedance on both leads were within 250-2000 ohms in monopolar range, and the patient was programmed at 0.8 v, 60 usec pw, 130 hz on c+/3- and 0.8 v, 60 usec pw, 130 hz on c+/11-.No follow-up image control had been done on the patient, and lead wrap around the ins was not confirmed by the physician.Ins data was not available.Oor was seen with ins amplitude at 0.8v and 1.2 v.The patient still had therapy when stimulation was just below the oor value because the patient still felt the side effects of deep brain stimulation (dbs).The physician had not attempted programming bipolar settings.It was reported that the patient received an out of regulation (oor) error on the patient programmer again.The issue occurred when the patient wanted to adjust the stimulation amplitude by.1v on one of the leads.The patient's settings were.8v, 60us and 130 hz on the left and right.The impedance measurement of the system was not known.There were no symptoms reported.It was reported that electrode impedances and therapy impedances have been taken and there were no abnormalities found.The patient visited the clinic and their therapy was successfully increased from.8v to 1.1v due to side effects the patient was receiving from therapy.The cause of the oor was not determined.It was noted that turning the ins off and back on did not resolve the issue.The oor message still pops up from time to time.The patient will be closely monitored by the hcp.

Manufacturer Narrative

Additional review indicates that information from manufacturer¿s report #3004209178-2018-27988 was already reported in this report ( #3007566237-2018-03725).Any additional information regarding that event will be submitted as a supplemental submission to this report.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 8202364
• MDR Text Key: 131599552
• Report Number: 3007566237-2018-03725
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1