MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT XR PROCLAIM SCS SYSTEM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Patient Problems Muscle Weakness (1967); Pain (1994); Drug Resistant Bacterial Infection (4553)

Event Date 09/30/2022

Event Type  Injury  

Event Description

I had a spinal cord stimulator implanted and immediately contracted mrsa (methicillin-resistant staphylococcus aureus).I took antibiotics for 2 months before the unit had to be removed.I have ra (rheumatoid arthritis) so now i can no longer use medications like humira.I cannot sue anyone because i don't know exactly where it came from (as in doctor, hospital or the device itself) now, i am weak and incurably in pain for the rest of my life.I am not yet 55 years old!.

• Brand Name: ABBOTT XR PROCLAIM SCS SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18058435
• MDR Text Key: 327301129
• Report Number: MW5147651
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: VITAMIN D.; ALEVE.; ALKA SELTZER PLUS COLD.; ARMOUR THYROID.; BENAZEPRIL.; DEXILANT.; EXCEDRIN.; HYDROCODONE.; HYDROXYCHLOROQUINE.; MONOLUKAST.; MULTIVITAMIN.; NIACIN.; PHENTERMINE.; PREGABALIN.; TIZANIDINE.; VITAMIN B COMPLEX.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Other; Disability
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White