MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3244

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

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 1 of 4: reference mfr.Report#: 1627487-2018-06124 reference mfr.Report#: 3006705815-2018-01533 reference mfr.Report#: 1627487-2018-06125 it was reported the patient's leads had pulled out from the ipg header.X-rays confirmed the issue.As such, the patient was without stimulation.In turn, the patient underwent surgical intervention on (b)(6) 2018, wherein the extension was explanted and replaced with new ones.It was noted an additional extension was placed to provide maximum flexibility.The ipg is now connected via the new extensions.Reportedly, effective therapy was restored following the procedure.

Event Description

Device 1 of 4 : reference mfr.Report#: 1627487-2018-06124 , reference mfr.Report#: 3006705815-2018-01533 , reference mfr.Report#: 1627487-2018-06125.

• Brand Name: LAMITRODE 44 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
• Manufacturer Contact: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7653213
• MDR Text Key: 112836442
• Report Number: 1627487-2018-06123
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734406215
• UDI-Public: 05414734406215
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2018
• Device Model Number: 3244
• Device Lot Number: 5614584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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 Weight: 82