MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number 3146

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Increased Sensitivity (2065)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturer¿s evaluation: the complaint of infection can not be confirmed via laboratory testing.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.(b)(4).

Event Description

Device 3 of 4.Reference mfr.Report# 1627487-2016-01290.Reference mfr.Report# 1627487-2016-01294.Reference mfr.Report# 1627487-2016-01297.It was reported the patient experienced infection at the ipg site (date of event unknown).The patient was prescribed oral antibiotics.Further follow up identified the ipg site appeared red and tender.The redness radiated to the leads too.The patient underwent surgical intervention on (b)(6) 2016 where the scs system was explanted.The cultures taken resulted in negative for infection.The patient received four leads of the same lot number (model: 3146; lot # 171366).Additionally, the patient has three extensions.Two of them are from same lot number (model: 3341; lot # 115142).

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• 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: 5503570
• MDR Text Key: 40404379
• Report Number: 1627487-2016-01295
• 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: Other
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2010
• Device Model Number: 3146
• Device Lot Number: 171366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2008
• 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