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

Model Number 3788

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

Patient Problems Erythema (1840); Discharge (2225); Post Operative Wound Infection (2446)

Event Date 08/20/2014

Event Type  Injury  

Event Description

Device 2 of 2 reference mfr report#: 1627487-2014-05653.The patient had an scs system including two leads (from the same lot) for off-label use.It was reported one of the patient's leads had eroded through her skin.As a result, the patient underwent surgical intervention.During the procedure, the lead and ipg site were found to be slightly red.The lead and ipg site were also found to be infected.Pus was also present at the lead and ipg site.Next, the patient's scs system was explanted.In turn, cultures were taken and the patient was given antibiotics.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: review of the dhr for lead found in-process nonconformance related to foreign material in the kit.However, the individual affected devices were reworked per approved rework procedures and all devices within the lot met acceptance criteria.The dhr nonconformance is not related to the alleged device complaint.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.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4098631
• MDR Text Key: 4840821
• Report Number: 1627487-2014-05654
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 08/20/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 3788
• Device Lot Number: 4364197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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): Other
• Patient Age: 59 YR