MAUDE Adverse Event Report: ST JUDE MEDICAL, NEUROMODULATION GENESISXP

Model Number 3609

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591)

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

Event Date 09/27/2014

Event Type  Injury  

Event Description

The pt reports that she turned off her stimulation off and received a battery low message on her programmer.The pt continues to use her stimulation until the battery is fully depleted.Follow up info identified that an allergy test was performed and the pt has an allergy to stainless steel.The pt underwent surgical intervention to remove and replace the ipg; however, the physician opened the incorrect incision and had to close and implant the ipg into another pocket site.The issue is resolved.

Manufacturer Narrative

(b)(4).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: GENESISXP
• Manufacturer (Section D): ST JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4337783
• MDR Text Key: 21086639
• Report Number: 1627487-2014-22023
• 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: Consumer
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Model Number: 3609
• Device Lot Number: 2751810
• Other Device ID Number: 05414734402729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• 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 3186,; IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 52 YR