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 Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Injury (2348); Numbness (2415); Paraplegia (2448); Ambulation Difficulties (2544)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3888-33, explanted: (b)(6) 2016, product type: lead.Product id: 39565-30, lot# 0210400420, implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.(b)(4).

Event Description

The health care provider (hcp) reported via the company representative (rep) that the patient experienced loss of effectiveness, resulting in a revision of explant of four leads.A surgical lead was implanted.During the following night after surgery, the patient lost sensation in both legs.The next day the surgical lead was explanted due to incomplete paraplegia.The issue was not resolved at the time of this report.The patient was alive with injury.The rep reported two and a half weeks later that the patient was now in a rehabilitation clinic.Three days ago the patient could stand up for the first time and two days ago the patient could walk three steps with help.If additional information is received, a follow up report will be sent.

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

The rep reported over a month later that the patient has back and leg pain after multiple operations of the back for years.In the beginning the doctor implanted two epidural leads for the leg pain.The patient had never a complete paresthesia in the painful area of the legs.There was also no good paresthesia for the back pain.So they decided to implant two subcutaneous leads for the back pain.The patient was very satisfied with this therapy, except the lateral part of the leg was not very good covered by paresthesia.Then the patient had depression last summer.After this, the patient decided to make a new operation to receive a better coverage of the painful area in the legs.Because the first implantation of the epidural leads was very traumatic for the patient, they decide to implant a paddle lead in general anesthesia.

• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5504211
• MDR Text Key: 40445643
• Report Number: 3007566237-2016-01393
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• 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: 03/29/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 00048 YR