MAUDE Adverse Event Report: MEDTRONIC ACTIVIA PC; DEEP BRAIN STIMULATOR

Model Number 37601

Device Problem Defective Device (2588)

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

Event Date 11/21/2019

Event Type  malfunction  

Event Description

Surgeon found device to have fluid in generator during battery change.

• Brand Name: ACTIVIA PC
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): MEDTRONIC; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 9511044
• MDR Text Key: 172439155
• Report Number: 9511044
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA