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

Model Number 3788

Device Problem Failure to Advance (2524)

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

Event Date 11/17/2014

Event Type  Injury  

Event Description

It was reported during the patient's lead revision procedure (reference mfr.Report# 1627487-2014-08473) the physician had trouble placing the lead in the ipg header.The physician tried troubleshooting to no avail.Subsequently, the physician explanted the ipg and replaced it with a new one which has resolved the issue.The patient has effective therapy post-operatively.

Manufacturer Narrative

(b)(4).This ipg serial number was included in field advisories.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; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4310307
• MDR Text Key: 5270398
• Report Number: 1627487-2014-20491
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010032
• 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
• Report Date: 11/17/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 3788
• Device Lot Number: 3199437
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Treatment: MODEL 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 51 YR