MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37612

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that he was trying to connect with the ins using the communicator and dbs therapy app on the handset, but was seeing "incompatibility found- service code 602" upon tapping on the 'open' box.Troubleshooting was attempted but they were having wi-fi issues.Additional information was received from a manufacturer representative (rep) reporting they linked up yesterday to troubleshoot.The cause of the 602 error was never determined.For the first 20 minutes, they were unable to interrogate the battery using their clinician tablet.It would say 'device not found'.When they tried to use the patient's handset, an error code popped up saying "visit clinician.You may require an update." they were able to interrogate the patient's other battery with their tablet.They then decided to try to connect with their legacy patient programmer (pp) and got the "ins in the box" icon.After they did this, everything worked as normal.They were unable to recreate a scenario that would bring up the error code.They checked the patient's recharger and all the apps on the patient handset and everything worked properly.The cause of the implantable neurostimulator (ins) in the box icon was not determined.They powered on and off the patient programmer (pp) and was unable to get the ins in the box icon again.They were able to interrogate the ins with the clinician tablet after the ins in the box icon.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the logs related to the event were deleted.

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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11378971
• MDR Text Key: 244114368
• Report Number: 3004209178-2021-03246
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 74 YR