MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

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

Patient Problems Seroma (2069); Swelling (2091); Foreign Body In Patient (2687)

Event Date 06/20/2015

Event Type  Injury  

Event Description

It was reported the patient had a seroma at the ipg site and the ipg site was swollen.The physician drained the ipg site but could not provide resolution.A culture of the fluid was taken and the results came back as negative for infection.As a result, the patient underwent surgical intervention on (b)(6) 2015.During the surgery, a (b)(4) sponge was found left in the ipg pocket from the initial implant surgery on (b)(6) 2015.The doctor then removed the (b)(4) sponge and rinsed the ipg pocket with antibiotic.The existing ipg was reimplanted.After the surgery, the patient was given oral antibiotic.Follow-up revealed the patient has completed the antibiotic and the issue has resolved over time.

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.Udi (di): (b)(4).

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: lu han ; 6901 preston rd; plano, TX 75024 ; 9723098568
• MDR Report Key: 4910443
• MDR Text Key: 6834023
• Report Number: 1627487-2015-07380
• 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: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3789
• Device Lot Number: 4976385
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• 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: 3341 (X2), SCS EXTENSIONS; MODEL: 3159 (X4), SCS LEADS
• Patient Outcome(s): Other
• Patient Age: 56 YR