MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report#1627487-2018-02433.It was reported during replacement of the scs system (reference mfr.Report 31627487-2018-02143), the distal tip end of the second lead separated when the physician was attempting to remove it.Reportedly, the broken lead was left inside the patient and the remaining system devices were explanted and replaced as scheduled.Postoperatively, effective therapy was established with the new system.Both leads are being reported as it is unknown which lead was broken.

Manufacturer Narrative

Corrected data: concomitant medical products: associated device 1194 model # inadvertently entered incorrectly as 3394.

Event Description

Device 2 of 2, reference mfr.Report#1627487-2018-02433.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7345131
• MDR Text Key: 102623832
• Report Number: 1627487-2018-02434
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 3186
• Device Lot Number: 3769778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• 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: MODE, 3394(2),SCS ANCHOR; MODEL 3788, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 98