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

Model Number 3688

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994)

Event Date 05/15/2014

Event Type  Injury  

Event Description

It was reported the pt (b)(6) presented to the er due to pain at the ipg site.It was determined the pt's ipg was eroding through the ipg pocket.The patient was admitted to the hospital.Antibiotic therapy was started and the pt's ipg was explanted.It was noted the pt suffers from ehlers danlos syndrome (eds).The surgeon suspects this could be the cause of the reported event as there was no scar tissue formation around the ipg.In addition, it was reported the pt is confined to a wheelchair during the day due to an amputated leg.No further info was available at the time of this report.

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: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3890955
• MDR Text Key: 4676864
• Report Number: 1627487-2014-10127
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2013
• Device Model Number: 3688
• Device Lot Number: 3504460
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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
• Patient Outcome(s): Hospitalization