MAUDE Adverse Event Report: ABBOTT MEDICAL; STIMULATOR, SPINAL CORD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

This device was not placed at this facility.It was originally placed at another user facility a few years ago.The stimulator was reprogrammed in 2016.A few months ago the patient presented with complaints of (feeling like the stimulator was turning on by itself).The patient felt that she had a "hot, burning" sensation in the lower back with spasms in the right paraspinal region.She also complained of pain spreading all over her body.The device was explanted and the abbott rep was notified.

• Type of Device: STIMULATOR, SPINAL CORD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 8309761
• MDR Text Key: 135150229
• Report Number: 8309761
• Device Sequence Number: 1
• Product Code: GZB
• 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: 01/29/2019,01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 01/29/2019
• Date Report to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA