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

Model Number 3643

Device Problem Low Battery (2584)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/20/2013

Event Type  Injury  

Event Description

It was reported the pt had his scs ipg replaced.An sjm rep did not meet with the pt prior to the surgery on (b)(6) 2014 or have any knowledge of the ipg depletion.The pt's ipg was replaced with a different model ipg.

Manufacturer Narrative

Sjm has limited info 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: GENESIS
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3850641
• MDR Text Key: 19722132
• Report Number: 1627487-2014-02374
• 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: 05/06/2014

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 Expiration Date: 07/01/2013
• Device Model Number: 3643
• Device Lot Number: 3434665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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 3166 (X2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 52 YR