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

Patient Problems Discomfort (2330); Numbness (2415)

Event Type  Injury  

Event Description

Reporter called to submit a report about the adverse effects she is experiencing from spinal cord pain stimulator.The reporter stated, she asked her doctor to take out the battery as it is painful and giving her discomfort on her seating area.She thinks the battery must be defective to give her all those issues.She also said she feels her right leg gets numb, when she is trying to move after resting.She said, the doctor explained to her that if he takes out the battery alone, ¿the lead wire is not protected from burning¿.As a result, he refused to take out the battery, explaining to her that, he either has to take out the whole system or leave it as is.She said she does not want to whole system to be explanted, since it would be a major surgery.She went on saying, that she had a lot of surgeries before, and she does not want to have another one.She said, she received a letter from abbott regarding her device, asking her to contact them via phone.She is planning to contact them after she submits her report to fda.

• Brand Name: PROCLAIMXR SCS SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18102213
• MDR Text Key: 327992421
• Report Number: MW5147976
• 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: 11/08/2023

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic