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

Model Number 3186

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

Patient Problems Staphylococcus Aureus (2058); Post Operative Wound Infection (2446)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturer¿s evaluation: product testing will not be performed as the cause of the reported complaint cannot be determined through such means.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 2 of 4: reference mfr.Report #3006705815-2016-00125; 1627487-2016-01481; 1627487-2016-01482.It was reported the patient was diagnosed with (b)(6).The patient's infection is systemic.The patient was prescribed antibiotics to treat her infection and will follow up with her physician to determine if any further action is necessary to address the issue.The patient has two model 1192 anchors from the same lot implanted as part of her scs system.

Event Description

Device 2 of 4.Reference mfr.Report #3006705815-2016-00125; 1627487-2016-01481; 1627487-2016-01482.Additional information received identified the patient's infection has reportedly resolved.

• Brand Name: OCTRODE 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: 5523016
• MDR Text Key: 41060048
• Report Number: 1627487-2016-01479
• 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,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3186
• Device Lot Number: 4993941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2015
• 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: 44 YR