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 Edema (1820); Post Operative Wound Infection (2446)

Event Date 11/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.(b)(4).

Event Description

Device #1 of 4 reference mfr.Report: 1627487-2014-26989.Reference mfr.Report: 1627487-2014-26990.Reference mfr.Report: 1627487-2014-26991.The patient has a scs system which includes two anchors from the same lot.It was reported the patient was experiencing cellulitis at her incision sites and has been prescribed antibiotics.Surgical intervention may be pending to address this issue.This report was originally submitted on 12/05/2014 under mfr report # 0001627487-.2014-26988 the filing is hereby resubmitted to reflect the appropriate mfr report number.

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 4: reference mfr.Report: 1627487-2014-26989.Reference mfr.Report: 1627487-2014-26990.Reference mfr.Report: 1627487-2014-26991.Follow up information identified the infection initially appeared to have cleared, and antibiotics were going to be discontinued, however; the incisions began draining.The patient underwent surgical intervention to remove the scs system.The infection was at the ipg site and the lead incisions appeared to be normal.The patient is currently on antibiotics.The explanted products were sent for culture.This report was originally submitted on (b)(4) 2014 under mfr report # 0001627487-2014-26988.The filing is hereby resubmitted to reflect the appropriate mfr report number.

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 4: reference mfr.Report: 1627487-2014-26989, 1627487-2014-26990, 1627487-2014-26991.Follow up information identified the patient was doing okay.This report was originally submitted on 02/02/2015 under mfr report # 0001627487-2015-26988.The filing is hereby resubmitted to reflect the appropriate mfr report number.

• 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; 6901 preston rd; plano TX 75024
• MDR Report Key: 5166928
• MDR Text Key: 28900458
• Report Number: 1627487-2014-26988
• 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,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 3789
• Device Lot Number: 4742894
• Other Device ID Number: 05414734405690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR