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

Model Number 3009

Device Problem Connection Problem (2900)

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

Event Date 03/13/2014

Event Type  malfunction  

Event Description

The pt ((b)(6)) received a trial scs sys which included a trial cable.It was reported during the trial period, one of the trial cables would not lock the lead in place.The lead slipped out of the trial cable and could not be used by the multi-program trial stimulation device (mts).The trial cable was replaced which resolved the reported issue.

Manufacturer Narrative

Evaluation codes: results: complaint was confirmed for "loose connection." as received, a loose connection was observed when pt scenario was recreated with test control leads; consistent with the observation made in the field.The locking mechanism was malfunctioning.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt'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: 3969492
• MDR Text Key: 4612760
• Report Number: 1627487-2014-10106
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

• Date FDA Received: 05/13/2014
• 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: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• 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: 3219