MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION TRIAL CABLE; SCS TRIAL CABLE

Model Number 3009

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2013

Event Type  malfunction  

Event Description

The patient ((b)(6)) rec'd a trial scs system which included a trial cable.It was reported the leads were disconnecting from the trial cable, even when in the locked position.In addition, an open circuit message was displayed on the multi-program trial stimulation device (mts).Upon inspection, it was noticed that the mechanism of the trial cable was not gripping the trial lead tightly in the locked position and could be easily disconnected.The trial cable was replaced which resolved the reported issue.

Manufacturer Narrative

Evaluation codes: results: the complaint of "loose connection" was confirmed.As rec'd, a loose connection was observed when test control leads were inserted into the returned ete cables.Sjm has limited info 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: TRIAL CABLE
• Type of Device: SCS TRIAL CABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3969493
• MDR Text Key: 4629123
• Report Number: 1627487-2014-10105
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: SCS LEAD, MODEL 3186; IMPLANT DATE: