MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3186

Device Problem Difficult to Advance (2920)

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

Event Date 06/17/2014

Event Type  Injury  

Event Description

It was reported during the patient's permanent implant procedure, the physician was unable to remove the stylet from the first lead.As a result, the physician cut the stylet and left it implanted in the lead.Additionally, the physician encountered difficulty implanting the leads due to patient anatomy.Although the first lead was successfully implanted, the physician abandoned the placement of the second lead(same lot number) as the patient experienced discomfort.The procedure was extended by an hour due to these incidents.The patient is receiving effective stimulation.

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: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3946515
• MDR Text Key: 4643835
• Report Number: 1627487-2014-21458
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: 3186
• Device Lot Number: 4509077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 3788; IMPLANTE DATE:; SCS ANCHOR, MODEL: 1192; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 74 YR