MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number 3169

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 1 of 2.Reference mfr report: 1627487-2016-06552.It was reported the patient experienced an infection at the right supraorbital lead (off-label) site.The patient was prescribed antibiotics, however upon completion of the antibiotics the infection had not appeared to resolve.The lead incision site was also dehisced and the lead was exposed.The lead was explanted.It is unknown which lead was the right supraorbital lead; therefore both supraorbital leads are being reported.

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

Device 1 of 2: reference mfr report: 1627487-2016-06552.Additional information indicated the patient reported the infection was determined to be staphylococcus and she was continuing treatment with antibiotics.Also, while the infection was initially located at the right supra orbital lead site, it was later found to also be at the left supra orbital lead site and was treated with antibiotics.The patient consulted with an infectious disease physician and it was determined the infection had resolved.The left supra orbital lead remains implanted.

Event Description

Device 1 of 2: reference mfr report: 1627487-2016-06552.Further information received indicated the left supra orbital lead site was found to be infected.Surgical intervention is pending to address the issue.

Event Description

Device 1 of 2: reference mfr report: 1627487-2016-06552.Further information received indicated the patient's left supraorbital lead was explanted on (b)(6) 2017.The patient is to remain on antibiotics.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2016-06552.Further information received indicated the patient completed a 3 month antibiotic regime and results of recent blood work were normal.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2016-06552.Additional information received indicated the infection has resolved.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 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: 6196237
• MDR Text Key: 63025466
• Report Number: 1627487-2016-06551
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• 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,Followup,Followup,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3169
• Device Lot Number: 5301432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• 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
• Treatment: MODEL 3169 (X2), SCS LEAD; MODEL 3341 (X2), SCS EXTENSION; MODEL 3771, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 49 YR