MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EONC

Model Number 3688

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 12/20/2013

Event Type  Injury  

Event Description

It was reported the pt is experiencing pain at his scs ipg pocket site due to the scs ipg being too large for his body build.Subsequently, surgical intervention will be taken at a later date to address the issue.

Manufacturer Narrative

Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EONC
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston road; plano, TX 75024 ; 9725264637
• MDR Report Key: 3581155
• MDR Text Key: 4163101
• Report Number: 1627487-2014-03043
• 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: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: 3688
• Device Lot Number: 4003266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3228
• Patient Outcome(s): Other
• Patient Age: 57 YR