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

Model Number 37601

Device Problems Unintended Collision (1429); Unable to Obtain Readings (1516); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Dysphasia (2195)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 37642, product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer who reported they had a fall on october 12th and spoke with their managing healthcare provider (hcp).The hcp had them do two ct scans, and the scans showed all implantable components were fine.The consumer had not had any return of symptoms after the fall, besides a slight change in speech (the consumer didn¿t know when this happened exactly, but it was after their fall).The consumer spoke with their therapist and managing hcp october 16th who tried to walk them through how to check if their stimulation was still on, and the consumer saw an out of regulation (oor) message.The meaning of the oor message as well as how to bypass it was reviewed, but in order to permanently clear the message, the consumer would need to go into the hcp¿s office.The consumer successfully bypassed the oor message and saw on and okay (along with 2.9 a 3.2 for stimulation settings).Additional information was received from the manufacturer¿s representative (rep) who reported the consumer saw an out of regulation (oor) message after checking the implantable neurostimulator (ins) after a second fall at the end of last week.The consumer was in voltage mode.The meaning of the oor message was reviewed along with ways to possibly address the oor message.At the current time they hadn't found any suspect impedance values.The rep called again and sated the consumer saw their healthcare provider (hcp) one week ago after an initial fall two weeks ago who did a regular impedance check and it was ¿fine.¿ when the hcp ran therapy impedances on the right stn they saw dashes where the impedance should be.The hcp reprogrammed the consumer on the right stn into monopolar stim setting and therapy impedances were normal.The doc then programmed back into the original bipolar configurations and ran therapy impedances and it was ¿fine¿-no dashes.The rep stated the hcp was with the consumer today checking on the system after the second fall, and the hcp was seeing dashes again where the impedance should be in the therapy impedance section.The rep stated the hcp had the most up to date version of the clinician app.Possible interference was reviewed with the rep, along with trying to increase stimulation on the program in question and run therapy impedance testing again.The rep noted while talking to the hcp today, they had the hcp put the consumer into different positions and run therapy impedances, but only got dashes.

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 the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the oor message was unknown.To resolve the issue the hcp tested the patient programmer (pp) in clinic and the oor didn¿t register.The cause of the dashes when therapy impedances were performed was unknown.To try and resolve the issue impedances were retested with different positional tests, but the oor didn¿t resolve.

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 was received from the patient stating that she went to the health care provider (hcp) as recommended and at first the hcp did not know how to resolve it but then the hcp was able to clear the oor.Patient stated she called just to make sure that the oor was cleared.Patient was walked through how to connect and patient saw normal therapy screen, confirming everything was working as intended.

• 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 00777
• MDR Report Key: 10711932
• MDR Text Key: 212321349
• Report Number: 3004209178-2020-18402
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 71 YR