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

Model Number 3244

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 09/06/2012

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 3.Reference mfr report#1627487-2018-05340, reference mfr report#1627487-2018-05341.It was reported the patient experienced uncomfortable stimulation described as shocking sensation in the low back ever since the scs system was implanted.As a result, surgical intervention may be pending to address the issue.

Event Description

Device 1 of 3: reference mfr report#1627487-2018-05340; reference mfr report#1627487-2018-05341.Additional information identified that surgical intervention was undertaken wherein the leads were explanted and replaced.Patient is reportedly receiving effective therapy.Issue has been resolved.

• 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
• MDR Report Key: 7563030
• MDR Text Key: 109880369
• Report Number: 1627487-2018-04948
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 3244
• Device Lot Number: 3486460
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2011
• 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: 47 YR
• Patient Weight: 73