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

Device Problem Pocket Stimulation (1463)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Device 2 of 2.Ref mfr report # 1627487-2014-00429.

Manufacturer Narrative

This ipg serial number was included in a field advisory.Sjm 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: UNK
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: courtney weddington ; 6901 preston rd; plano, TX 75024 ; 9725264859
• MDR Report Key: 3962495
• MDR Text Key: 4558404
• Report Number: 1627487-2014-00430
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/19/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/14/2014
• 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
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR