MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3246

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/30/2017

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 3 of 3 reference mfr.Report: 1627487-2017-08623 ,reference mfr.Report: 1627487-2017-08674.It was reported the patient's leads were fractured.Subsequently, surgical intervention was undertaken to address the issue.The physician experienced difficulty removing the leads as the leads were stuck in the ipg header.The leads and ipg were successfully explanted and replaced.Stimulation was restored following the procedure.

Event Description

Device 3 of 3 , reference mfr.Report: 1627487-2017-08623.Reference mfr.Report: 1627487-2017-08674.

• Brand Name: LAMITRODE S-4 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: 7143460
• MDR Text Key: 95655548
• Report Number: 1627487-2017-08675
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2006
• Device Model Number: 3246
• Device Lot Number: 34298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2004
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR