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

Model Number 3716

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

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 04/18/2014

Event Type  Injury  

Event Description

It was reported the patient's thoracic scs system was explanted due to infection.The patient's physician observed an abscess in the patient's low back, near the ipg.Cultures were taken and the patient was treated with both iv and oral antibiotics.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.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

Mfr's evaluation: the returned product was not analyzed as the complaint of infection could not be confirmed via lab testing.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.

Event Description

Follow up identified the patient's physician reported the patient is doing well.

Manufacturer Narrative

Review of the patient's medical record revealed the explant date in the initial report is incorrect.

Event Description

Review of the patient's medical record revealed the reported ipg was part of the patient's cervical scs system not the thoracis scs system as previously reported.

• Brand Name: EON
• 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: 3850678
• MDR Text Key: 21728572
• Report Number: 1627487-2014-02353
• 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: Health Professional,health professional,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2016

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: 06/01/2012
• Device Model Number: 3716
• Device Lot Number: 3145874
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: 02/12/2016; 02/12/2016
• Supplement Dates FDA Received: 06/20/2014; 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3186 (X2); IMPLANT DATE:; SCS ANCHOR: MODEL 1194 (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR