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

Model Number 37601

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

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

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient went into the hospital for some issues and the deep brain stimulation (dbs) was interfering with the ekgs and heart monitors so they turned the dbs off.They stated the patient ended up getting a pacemaker defibrillator implanted.They went to try to turn the dbs back on while they were in a medical setting and it wouldn't "pair." they stated that they did not want to attempt to turn it on if there is no medical professional there.Additional information was received from the consumer reporting that a manufacturer representative (rep) met them at the cardiology appointment and resolved the issue.The deep brain stimulation (dbs) is in working order.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11942635
• MDR Text Key: 263465176
• Report Number: 3004209178-2021-08890
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/04/2021
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1