MAUDE Adverse Event Report: MEDTRONIC, INC. ACTIVA SC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number 37603

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Patient scheduled for dbs generator removal and replacement in or.Manufacturer response for activa sc, activa sc (per site reporter); responsive.

• Brand Name: ACTIVA SC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11228856
• MDR Text Key: 228633815
• Report Number: 11228856
• Device Sequence Number: 1
• Product Code: NHL
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37603
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA