MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

Device Problem Corroded (1131)

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

Event Date 11/03/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr.Report# 1627487-2014-20449.

Manufacturer Narrative

Udi (di): (b)(4).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.

Event Description

Device 2 of 2.Reference mfr.Report# 1627487-2014-20449.

Manufacturer Narrative

Result: the complaint of ¿corrosion¿ was not confirmed.As received, microscopic inspection revealed broken wires in lead extension ¿a¿ 43 cm away from the stimulation end.However, the outer tubing was not breached at the fracture site.The fracture was consistent with an overstress condition the lead was subjected to while it was inside the patient.As received, lead extension ¿b¿ was clear; both the header and terminal ends were in good condition, and no broken wires or kinks in the lead body were observed.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: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS EXTENSION
• 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: 4274637
• MDR Text Key: 5228464
• Report Number: 1627487-2014-20450
• 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
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 3346
• Device Lot Number: 4194321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• 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: MODEL 3788, SCS IPG; MODEL 3169(2), SCS LEAD; MODEL 3166(2), SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 58 YR