MAUDE Adverse Event Report: ST. JUDE SPINAL CORD STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 06/09/2017

Event Type  Injury  

Event Description

St.Jude spinal cord stimulator off but was reprogrammed by (b)(6), gave me a new hand held programmer because original from another recall failed to turn on scs after charging after surgery that i had (b)(6) 2017.Immediately started severe shocks to unusual parts of my body, disabling my muscles.Was completely turned off but was still shocking several areas that the doctor, (b)(6) was unable to explain so i requested immediate removal since implanted by mistake in (b)(6) 2010 by(b)(6) without my consent.Since no improvement by device they implanted in (b)(6) 2004.False medical records written by (b)(6) who refused to provide to me with amendments as (b)(6) law requires never reported lower back pain radiating down both legs falsified by dr.(b)(6).Was dumped by (b)(6) when i saw an insurance record falsely written for reason for implant paid by (b)(6).Dr.(b)(6) and (b)(6) wrote false surgical record as well as icu for wrong surgical mistake (b)(6) 2000 as refused to provide medical record for me or another doctor to correctly treat new leg pain caused by bad surgery by dr.(b)(6) and dr.(b)(6) of (b)(6) who wrote referral to dr.(b)(6) incorrectly then destroyed my med record before the surgery violating fed and state laws.Please prosecute as no meetings.About implant of scs malfunction now causing inability to walk.

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 6692818
• MDR Text Key: 79526705
• Report Number: MW5070840
• 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: 07/05/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 68