MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

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

Patient Problems Weakness (2145); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report #: 3006705815-2018-00797.It was reported that the patient experienced leg weakness since the implant of his device on (b)(6) 2018.In turn, the patient went to the emergency room on (b)(6) 2018 in which he was later released after a (b)(6)work up.Reportedly, the patient was later seen for his post-operative appointment and was still experiencing leg weakness associated with standing especially in his left leg.Computed tomography (ct) scan was done and was negative.The patient plans to have a doppler study.Follow up revealed the patient was feeling better and was able to ambulate.

Event Description

Device 2 of 2.Reference mfr report #: 3006705815-2018-00797.Follow up revealed that the patient's leg weakness has improved by about 75%-80% and now has good coverage.Reportedly, the patient plans to take physical therapy to help with his mobility.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: taiwo babajide ; 6901 preston road; plano, TX 75024 ; 9723098568
• MDR Report Key: 7440388
• MDR Text Key: 105815883
• Report Number: 3006705815-2018-00798
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: 3186
• Device Lot Number: A000039177
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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
• Treatment: MODEL: 3660, SCS IPG
• Patient Outcome(s): Other