MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Stenosis (2263); Injury (2348)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that they stopped using stimulation in about (b)(6) 2016 because their spinal cord stimulator was not doing what it used to do and now when they tried to recharge, they were not able to connect to recharge.There was no trauma or falls reported to be related to the issue.It was reported that the patient had been hospitalized in (b)(6) and had gone to the er, 2 months ago, due to a lot of pain in their leg and groin.The patient was given medication for a week.There was a report that the patient had a mylogram ct scan which showed that they had stenosis and a bulging disc.The patient thought their stenosis was getting worse.They stopped using the stimulation, could not recharge, stimulator was not doing what it used to, and had leg and groin pain.The cause of the loss of therapy was not determined.It was noted that the device was still functional but no longer able to control the pain.Troubleshooting that was performed was a reprogramming, ct lumbar spine and electromyography (emg) to evaluate for new pathology.They had not assessed for an overdischarged battery and no symptomatic improvement from reprogramming.The healthcare professional (hcp) reported that the scs never worked very well for them.It was reported that the patient reinjured their back in early 2015 and had not been able to control the pain well since then using any modality.Relevant medical history includes chronic low back pain and spinal pain.

Event Description

It was further clarified that the patient had been hospitalized in (b)(6) 2015.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5971900
• MDR Text Key: 55419067
• Report Number: 3004209178-2016-19527
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Date Device Manufactured: 10/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR