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

Model Number 3688

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

Patient Problem Discomfort (2330)

Event Date 04/04/2014

Event Type  Injury  

Event Description

It was reported the pt's scs ipg was explanted and replaced with a different model due to experiencing pocket site discomfort as the original scs ipg was "too large" for the pt.Post-operative the pt was not experiencing discomfort with the new scs ipg.

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 3810765
• MDR Text Key: 4386230
• Report Number: 1627487-2014-03296
• 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: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2011
• Device Model Number: 3688
• Device Lot Number: 2832777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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: SCS LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 88 YR