MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION UNKNOWN; SCS LEAD

Model Number UNKNOWN

Device Problem Failure to Advance (2524)

Patient Problem Scar Tissue (2060)

Event Date 03/13/2014

Event Type  Injury  

Event Description

It was reported the pt's trial procedure was abandoned on (b)(6) 2014, after the physician was unable to advance the leads due to scar tissue and other factors.In turn, the pt was referred to another physician.

Manufacturer Narrative

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: UNKNOWN
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston road; plano, TX 75024 ; 9725264659
• MDR Report Key: 3733414
• MDR Text Key: 4271312
• Report Number: 1627487-2014-25251
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2014

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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other