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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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).

 
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Brand NameSPINAL CORD STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
ABBOTT MEDICAL
MDR Report Key12307445
MDR Text Key266245399
Report NumberMW5103150
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received08/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/10/2021 Patient Sequence Number: 1
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