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

Model Number 3383

Device Problems Detachment Of Device Component (1104); Hole In Material (1293)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2014-25266 and 1627487-2014-25267.It was reported the pt is not receiving stimulation.Diagnostics revealed no anomalies.X-rays identified the lead pulled out the ipg header.In turn, the pt underwent surgical intervention to address the issue.During the procedure, the pt's extensions were explanted and replaced due to one having a gouge.Additionally, the ipg was explanted and replaced due to one of the extension contact breaking and detaching in the header.

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: SINGLE EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston road; plano, TX 75024 ; 9725264659
• MDR Report Key: 3764649
• MDR Text Key: 4469701
• Report Number: 1627487-2014-25268
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 3383
• Device Lot Number: 3841858
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• 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 LEADS: MODEL: 3186 (X2)
• Patient Age: 73 YR