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

Model Number	37022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), product type: screening device.Product id: 977d260, serial# (b)(4), product type: screening device.Product id: 355531, lot# n722784, product type: screening device.
Event or Problem Description
Information was received from a consumer via a manufacturer's representative (rep) regarding an external neurostimulator.It was reported that the patient had pain.The patient's device was turned off and the symptoms continued.The intervention for the pain was the patient was tried with low dose therapy, but again was unsuccessful.Originally the patient was sent home on high dose setting, and woke up in severe pain and started to panic.The patient called 911 and the device was turned off at 1800 on (b)(6) 2017 and remained off until (b)(6) 2017.The paramedics took the patient to the hospital and was admitted on (b)(6) 2017 and discharged (b)(6) 2017.The patient was treated for pain and sent home.There were no neurological deficits.The patient was seen in the clinic, they were in extreme pain, but were moving all extremities.The patient did not want to turn the device on again.The patient tried the low dose therapy, where they reported improvement.The patient got up after being programmed to walk a few steps and began to have pain.The patient reported that they scream when they walk.The therapy was turned off at that point and the leads were removed without complications.The patient then proceeded to walk out of the clinic pushing their granddaughters stroller with the child in it.The patient's daughter reported that the patient was in extreme pain.No further complications were reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the manufacturer representative reported that the cause of the pain was not determined and the physician assumed it to be procedural pain.

• Brand Name: RESTORE
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6716962
• Report Number: 2182208-2017-01040
• Device Sequence Number: 1604599
• Product Code: LGW
• UDI-Device Identifier: 00643169513013
• UDI-Public: 00643169513013
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR