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

Model Number 37022

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are : product id: 977a290, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 37081-40, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: extension.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 18-oct-2020, udi#: (b)(4); product id: 37081-40, serial/lot #: (b)(4), ubd: 19-sep-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was trialing a neurostimulator.It was reported that after spinal cord stimulation testing and post-operative, the patient suddenly described that he was not able to move his left leg anymore.The hcp was informed and tested that with the patient.Approximately one hour later, the hcp called the rep again and informed them that now the patient wasn't able to move both legs.They assumed some kind of epidural bleeding and stopped the testing explanting the electrode and extension.The testing and steering of the electrode was quite challenging before and at the end they found a position approximately at the eleventh thoracic vertebrae (t11) with paresthesia in the left leg of the patient which was the pain area.Impedance was checked and was ok.Power in the operating room was approximately 2 volts.It was unknown if the issue was resolved as of (b)(6) 2018.The patient was alive with injury.The patient had the pre operation status and the patient¿s inability to move their legs was resolved.The healthcare professional (hcp) stated the patient¿s inability to move their legs was due to epidural bleeding.

Manufacturer Narrative

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

• Brand Name: RESTORE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7709955
• MDR Text Key: 114685531
• Report Number: 2182208-2018-01334
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• 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?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/01/2013
• 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): Required Intervention
• Patient Age: 89 YR