MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/01/2018

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: 1627487-2018-08528.It was reported the patient was experiencing an intermittent "shocking" sensation down her arm while switching between therapy programs.The patient stated the issue started following a motor vehicle accident.Reprogramming of the patient's scs system was performed, however the issue persisted.X-ray imaging showed one of the patient's leads had migrated.Surgical intervention may be taken to address the issue.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: arnulfo ochoa ; 6901 preston road; plano, TX 75024 ; 9723098090
• MDR Report Key: 7860340
• MDR Text Key: 119688236
• Report Number: 1627487-2018-08527
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 3189
• Device Lot Number: 6183583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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 (X2), SCS ANCHOR; MODEL 3662, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 39 YR