MAUDE Adverse Event Report: ABBOTT MEDICAL SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Paralysis (1997)

Event Date 08/03/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 patient had abbott spinal cord stimulator implanted by (b)(6) at (b)(6).Immediately after surgery pt was in severe pain with left leg weakness and right leg paralysis.Scs was turned off.Pt was sent home same day without assistance.Family members spent several hours to move pt into the split level home.Four days later, pain improved with oxycodone but pt still could not stand, no change in leg function.Pt self limited i/o due to inability to get to and on/off toilet.Pt contacted (b)(6) on (b)(6) 2021 and was told to go to ed at (b)(6).Fda safety report id# (b)(4).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 12307445
• MDR Text Key: 266245399
• Report Number: MW5103150
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/07/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR