MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION LAMITRODE S8; SCS LEAD

Model Number 3286

Device Problem Cut In Material (2454)

Patient Problems Scar Tissue (2060); Discomfort (2330)

Event Date 03/26/2014

Event Type  Injury  

Event Description

It was reported the pt was experiencing discomfort at the thoracic lead site that the physician believed to be due to scar tissue.In turn, the physician removed some scar tissue in attempt to alleviate the patient's discomfort on (b)(6) 2014.Additionally, it was unknown if the pt had effective coverage.During procedure the physician cut the lead.Asa result, the pt underwent surgical intervention on (b)(6) 2014 to replace the lead.Effective coverage was obtained post-op.It is unk if the physician partially explanted the cut lead.

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: LAMITRODE S8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3783235
• MDR Text Key: 4379018
• Report Number: 1627487-2014-25291
• 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: 03/26/2014

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: 08/01/2014
• Device Model Number: 3286
• Device Lot Number: 3782966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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: SCS ANCHORS, MODEL: 1192 (2X); IMPLAMT DATE:; SCS IPG, MODEL: 3788; IMPLANT DATE:; IMPLANT DATE:; SCS LEAD, MODEL: 3286
• Patient Outcome(s): Other
• Patient Age: 53 YR