MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44C; SCS LEAD

Model Number 3245

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2014

Event Type  Injury  

Event Description

It was reported during the patient's ipg replacement procedure (reference mfr report: 1627487-2014-26051), the physician inadvertently cut the lead.As a result, the lead was explanted and replaced and the procedure was extended by an hour due to this incident.It was reported the patient has effective stimulation post-operative.

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 44C
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3683359
• MDR Text Key: 21447796
• Report Number: 1627487-2014-21110
• 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: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: 3245
• Device Lot Number: 34229938
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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
• Treatment: SCS LEAD: MODEL 3183; SCS IPG: MODEL 3788; SCS ANCHOR: MODEL 1192; IMPLANT DATE:; IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 64 YR