MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTORE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Undesired Nerve Stimulation (1980); Paralysis (1997); Sepsis (2067); Septic Shock (2068); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446); Ambulation Difficulties (2544)

Event Date 03/01/2015

Event Type  Injury  

Event Description

Information was received from a trial patient.It was reported that 5 days after a trial was put in during (b)(6) 2015 the patient's incision got septic (infected) and the patient ended up on life support twice.The patient stated that they were paralyzed when they woke up the second time.It was also reported that it caused the patient to have lung issued.The patient still wore oxygen at night and could not walk without holding on to something.The patient had a pinched nerve in their spine and was experiencing some bad headaches as well.The patient had talked to someone in (b)(6) 2015 about how the trial was going and wanted to discuss options for any compensation for what they had been through as a result of the trial.

Manufacturer Narrative

"other" does not apply to this event.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.

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

Additional information was received during a telephone call with the health care professional (hcp) on 2016-11-03 reporting that the patient opted for the trial on (b)(6) 2015 and had not started to see the physician until (b)(6) 2015.The hcp records showed that the physician who had done the trial procedure recorded that the patient had stated that it had not helped.The patient went to the emergency room after the trial, a ct was performed on (b)(6) 2015, and an mri was performed on (b)(6) 2015.The patient was transferred multiple times between physicians.One physician had the patient for septic shock where multiple blood transfusions were performed.The patient was then transferred to another physician for physical therapy.All of this occurred before the patient had seen the current, reporting hcp office.The patient was in a wheel chair when they started to see the current hcp.The patient declined further mris with their current hcp and did not want anyone touching their back.No additional information was known and no device information was available to be provided.

• Brand Name: RESTORE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6035052
• MDR Text Key: 57682813
• Report Number: 3007566237-2016-03601
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• 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): Life Threatening; Other; Required Intervention; Disability