MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Event Description

It was reported the patient's ipg had eroded through his skin.As a result, the patient's scs system was explanted.During the procedure, cultures were taken and came back positive for staphylococcus epidermidis.The patient was given oral antibiotics to address the infection.The patient's issue resolved over time.

Event Description

It was reported the patient's ipg had eroded through her skin.As a result, the patient's scs system was explanted.During the procedure, cultures were taken and came back positive for staphylococcus epidermidis.The patient was given oral antibiotics to address the infection.The patient's issue resolved over time.

Manufacturer Narrative

(i initially reported within the details that the patient was a female by mistake).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.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Corrections/removal reporting number: 1627487-07262012-002-r.This ipg serial number is included in field advisories.(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: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4805616
• MDR Text Key: 5923821
• Report Number: 1627487-2015-05267
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

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: 11/28/2012
• Device Model Number: 3788
• Device Lot Number: 3249807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Treatment: MODEL: 3186(X2), SCS LEADS; MODEL: 1192(X2), SCS ANCHORS
• Patient Outcome(s): Other