MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC PRECISION SPECTRA SPINAL CORD STIMULATOR

Model Number IPG SC-1132

Device Problems Failure to Charge (1085); Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

It has been happening for some time.It has 2 issues, first one is that my stimulation keeps moving from low back into legs and feet to the point it hurts to walk; 2nd is a charging issue.Rep download info from battery to send to engineers on (b)(6) 2018.They reset my remote and tested my charging disk, they were fine.For the past month i have had issues that i can charge for up to 3 hrs and not get any charge.The battery can have 2 bars at 10pm, and by 5 pm next day it can depleted completely.It is very sporadic.Rep could not get stimulation back into the lumbar area at reprogramming.So i basically have a device that does not work and has difficulty charging.I did see fda gave it pma.The stimulator got reprogrammed about every 2-3 weeks because the stimulation dropped from my lumbar spine into my legs and feet, which causes the device to not do what it is implanted for, help relieve lumbar pain.It also causes pain and discomfort in my legs and feet if i turn the program on to one i can feel as once it shifts / moves, i no longer experience pain relief at all unless i lay on my back, as of (b)(6) 2017.

• Brand Name: BOSTON SCIENTIFIC PRECISION SPECTRA SPINAL CORD STIMULATOR
• Type of Device: BOSTON SCIENTIFIC PRECISION SPECTRA SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7789048
• MDR Text Key: 117568402
• Report Number: MW5079179
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IPG SC-1132
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 58