MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION DUAL EXTENSION; SCS EXTENSION

Model Number 3346

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 03/21/2014

Event Type  Injury  

Event Description

It was reported the patient experienced swelling and soreness at the extension sites.The physician relocated the extensions away from sore area.Note the patient received two extensions from the same lot number.

Manufacturer Narrative

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: DUAL EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3764872
• MDR Text Key: 4548611
• Report Number: 1627487-2014-12269
• 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: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2011
• Device Model Number: 3346
• Device Lot Number: 2884554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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 IPG: MODEL 3716; IMPLANT DATE:; SCS LEAD, MODEL 3149 (2); IMPLANT DATE:; SCS LEAD, MODEL 3166 (2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 65 YR