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

Model Number NEU_ENS_STIMULATOR

Device Problem Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Paraplegia (2448)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c290, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Product id: 977c290, serial/lot #: (b)(4), ubd: 31-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported that the lead was implanted due to indication of pain on level t9/t10.The patient was implanted in the past with several orthopedic spine screw systems.Due to the systems, there was not enough spinal space and it was difficult to implant the lead.After the implant, the patient complained of a lot of pain at the implant site of the lead.Where they got medication for their pain.Yesterday, the patient complained of paraplegic syndrome in the legs.Factors that may have led or contributed to the issue were not applicable.A ct scan was done where there was no epidural injury or bleeding visible.From the anatomical point of view, no abnormalities were existing.It was reported that the physician decided to explant the lead.The patient still complains of paraplegic syndromes but it seems that the symptoms decreased.The issue did not resolve.Additional information received that there was no implantable neurostimulator (ins) implanted.It was a trial with a lead.The patient was getting more and more well after explantation of the lead.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10285497
• MDR Text Key: 201666503
• Report Number: 2182207-2020-00532
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2020
• 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; Disability