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 Problems Abscess (1690); Post Operative Wound Infection (2446)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.St.Jude medical 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

Device #1 of 2: reference mfr.Report: 1627487-2017-04241.It was reported there was drainage at the lead anchor site.The physician identified an abscess had formed.The physician performed an incision and drainage on (b)(6) 2017.A culture was taken and it was positive for (b)(6).The patient is being treated with antibiotics.He patient was hospitalized for one week due to the infection and the patient returned to the hospital due to kidney failure related to the antibiotics.Follow up information identified surgical intervention is planned to remove the entire scs system on (b)(6) 2017 due to infection at the lead site.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2017-04241.Follow up information identified the patient underwent surgical intervention on (b)(6) 2017 where the entire scs system was explanted on (b)(6) 2017.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2017-04241.Follow up information identified the infection has not resolved and the patient remains on antibiotics.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2017-04241.Follow up information identified the infection has not resolved and the patient remains on antibiotics.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2017-04241.Follow up information identified the infection has not resolved and the patient remains on antibiotics.

• 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: 6776644
• MDR Text Key: 82131004
• Report Number: 1627487-2017-04240
• 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,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2019
• Device Model Number: 3228
• Device Lot Number: 5971372
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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 3772, SCS IPG
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR