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

Model Number 3228

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

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.

Event Description

It was reported that patient underwent surgical intervention on (b)(6) 2017 wherein the physician debrided the thoracic incision, re-anchored the lead tails, and closed the incision.

Event Description

Follow up revealed that the patient¿s mid-back incision is opening again.An allergy kit has been ordered by the physician to see if that is what¿s causing the repeated wound problems and there were no reactions found.Reportedly, patient underwent surgical intervention on (b)(6) 2017 wherein the surgeon created a skin flap over the part of the wound to close the incision.Cultures were taken but no results yet.

Event Description

Follow up revealed that the patient was diagnosed with an infection.Diagnostic test confirmed a staphylococcus infection.As a result, the patient underwent surgical intervention on (b)(6) 2018 to have the system explanted.Reportedly, the patient was treated with oral antibiotics.The infection resolved post operatively.

• Brand Name: PENTA 3MM LEAD, 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: 7058933
• MDR Text Key: 92921552
• Report Number: 1627487-2017-07500
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Model Number: 3228
• Device Lot Number: 6105714
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: MODEL: 3662, SCS IPG
• Patient Outcome(s): Other