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 Inflammation (1932); Swelling (2091); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Additional information received identified the patient's most recent scs ipg pocket site was relocated on (b)(6) 2015.The issue of inflammation was resolved with the surgical intervention.

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

This report was previously submitted on april 21, 2015 under mfr report number: 3006705815-2015-03155.It was reported the patient was experiencing inflammation (redness, swelling and drainage) per the physician at her current and original (ipg electively explanted and replaced) scs ipg pocket sites (date of event is unknown).The drainage was removed by the physician and the patient received steroids and antibiotics.As of (b)(6) 2015, the sites were "better" and the swelling had resolved.Surgical intervention regarding the position of the pocket site will be taken at a later date.

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.

• 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: rachel blackwell ; 6901 preston road; plano, TX 75024 ; 9725264637
• MDR Report Key: 4792991
• MDR Text Key: 5855004
• Report Number: 1627487-2015-03155
• 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: 04/28/2015

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: 11/30/2016
• Device Model Number: 3789
• Device Lot Number: 4890077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• 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 1192(2), SCS ANCHOR; MODEL 3189(2), SCS LEAD
• Patient Outcome(s): Other