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

Model Number 37603

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Device Overstimulation of Tissue (1991); Shock (2072); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient believes their deep brain stimulation (dbs) has been hacked.The patient was at a counselor appointment and started talking about "sensitive things" and in that moment, they experienced a strange sensation with their therapy.They described it as an extreme increase in stimulation, similar to when they were first programmed but more intense and "pushing the limit." they passed out in their chair for a moment and they were in shock.They said the counselor told them that they had a look of shock on their face when the episode happened and they couldn't focus after that and they were very traumatized.They have read articles online that it has happened to others.The patient was redirected to their healthcare provider to further address the issue.Refer to manufacturer report 3004209178-2021-13004 for related device.

• 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: 12375949
• MDR Text Key: 268432774
• Report Number: 3004209178-2021-13005
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Date Device Manufactured: 11/21/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 46 YR