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

Model Number 3186

Device Problems Fracture (1260); High impedance (1291); Material Twisted/Bent (2981)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/22/2018

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 1 of 2, reference mfr.Report#3006705815-2018-02379.It was reported the patient's scs system would not decrease in amplitude.Diagnostic testing identified high impedances on multiple contacts.Reprogramming was unable to resolve the issue.As a result, surgical intervention was undertaken on (b)(6) 2018 wherein both leads were explanted during the case.Reportedly, the leads were discovered kinked at the anchor site.

Event Description

Device 1 of 2.Reference mfr.Report#3006705815-2018-02379.Additional follow-up confirmed the patient received two replacement leads during the explant procedure on (b)(6) 2018.

Event Description

Device 1 of 2 : reference mfr.Report#3006705815-2018-02379.Follow-up identified the stimulation was restored postoperatively and the issue resolved.

• 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: melissa nkematu ; 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 7888739
• MDR Text Key: 120700787
• Report Number: 3006705815-2018-02378
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: 3186
• Device Lot Number: A000046328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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 1192(2), SCS ANCHOR; MODEL 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 54