MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problems Output Problem (3005); Positioning Problem (3009)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388); Neuralgia (4413)

Event Date 06/01/2018

Event Type  Injury  

Event Description

After having the battery of my mom's spinal cord stimulator moved to a more convenient location, the boston scientific rep turned the stimulator on, full power, and caused an excruciatingly painful nerve pain that started in her toe and traveled to her back.This pain is not helped by the stimulator and the back pain the stimulator was supposed to help has gotten worse.

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• MDR Report Key: 16502149
• MDR Text Key: 310956959
• Report Number: MW5115510
• 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: 03/02/2023

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Patient Sequence Number: 1
• Treatment: ELDERBERRY; FISH OIL; HIGH BLOOD PRESSURE MEDICATIONS; MELATONIN; MULTIVITAMIN; PLAVIX; THYROID MED; VITAMIN C
• Patient Outcome(s): Disability
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White