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

Model Number 37714

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 07/26/2013

Event Type  malfunction  

Event Description

Recall medtronic spine cord stimulator quit working, doctor helped to try to get it to work correctly and also the medtronic associate.Nothing worked right and they were getting tired of messing with me as they were a very busy practice.Medtronic's device quit working completely after 3 days, that is why it was recalled.I have asked several surgeons to remove it and they have all refused.It is painful and this recalled device no longer work and has not worked since 2013.My original doctor who implanted the device dr.(b)(6) said that he could remove the battery portion, not the leads but only if i had another device implanted.I then learned that my spinal cord stimulator model# 37714, serial number (b)(4) was recalled in may of 2016.I was never notified of this by medtronic or my dr.I have not been able to receive necessary mri's because i was informed if this wonderful device was implanted in to my body all would be well.I am in need of an mri to help diagnose having multiple sclerosis.I believe medtronic should pay for the removal of their device and to find a doctor who is willing to remove it.Fda safety report id# (b)(4).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15674197
• MDR Text Key: 302569504
• Report Number: MW5112860
• 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: 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 37714
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White