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 10/01/2013

Event Type  Injury  

Event Description

It was reported the pt was receiving low battery flags and the ipg stopped working several times.It was reported the pt was requesting for the scs system to be removed, as she wanted to pursue a different kind of surgery.The pt was advised to contact a physician for the removal.The parameters to determine if the ipg had reached normal end of life were not available.It was reported a physician explanted the scs system as requested.

Manufacturer Narrative

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: GENESIS
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3764377
• MDR Text Key: 18625986
• Report Number: 1627487-2014-04206
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/18/2014

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
• Device Expiration Date: 03/01/2012
• Device Model Number: 3643
• Device Lot Number: 3083979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 37 YR