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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Hematoma (1884); Paralysis (1997); Injury (2348)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977c190, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

The company representative (rep) reported the patient experienced leg paralysis two days after undergoing a spinal cord stimulation (scs) system implant procedure.An x-ray was performed.Device settings were unknown.Telemetry data was not available.No external factors contributed to the event.The action taken to resolve the issue was a laminectomy in lumbar part was performed.The issue was not resolved at the time of this report.The physician's observation regarding severity was considered severe.There was injury to the patient.It was noted that the device did not have contact with a patient with any infectious disease.The rep reported over two weeks later that lumbar partial resection surgery was performed, which did not resolve the palsy.No additional treatment/interventions were scheduled to resolve the palsy.The lead was positioned in the t-spine 7-9.In the physician's opinion, a hematoma caused the palsy.The physician considered about the possibility of a hematoma, during the procedure.The patient noticed leg paralysis on the second day post procedure.The patient needed writing communication due to hearing difficulties, the decisions and interventions could not be conducted promptly.The indication for use included low back pain due to failed back surgery syndrome (fbss) and dysacousis, hardness of hearing.

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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: 6080398
• MDR Text Key: 59219807
• Report Number: 3007566237-2016-03919
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• 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): Required Intervention; Disability