MEDTRONIC ACTIVA RC 37612

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-26 for MEDTRONIC ACTIVA RC 37612 manufactured by Medtronic.

Event Text Entries

[5225641] Lead fracture left. Family noticed increased dystonic movements at home and at school. Interrogation of dbs in office on (b)(6) 2014 showed high impedances and low therapeutic current delivered by the left brain stimulator. X-rays of head, neck, and chest were ordered to investigate lead fracture. Appointment made to see dr (b)(6) in three days. X-rays confirmed left electrode has fractured. Saw dr (b)(6) on (b)(6) 2014 to discuss options. No palpable fracture of dbs lead. No tenderness. The plan was discussed and decided upon, to replace the left dbs lead. Scheduling surgery date.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4284255
• MDR Report Key: 4284255
• Date Received: 2014-11-26
• Date of Report: 2014-11-18
• Date of Event: 2014-10-27
• Date Facility Aware: 2014-10-30
• Report Date: 2014-11-18
• Date Reported to FDA: 2014-11-18
• Date Reported to Mfgr: 2014-11-18
• Date Added to Maude: 2014-12-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDTRONIC
• Generic Name: DEEP BRAIN STIMULATOR (DBS)
• Product Code: GYZ
• Date Received: 2014-11-26
• Model Number: ACTIVA RC 37612
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC
• Manufacturer Address: MINNEAPOLIS MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-11-26