MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG; SCS IPG

Model Number 3771

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

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Hemorrhage/Bleeding (1888)

Event Date 01/05/2016

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

It was reported pus was present at the patient's ipg site after the doctor popped a blister.The patient's ipg site was also found to be healing improperly.In turn, the patient was given antibiotics as a precaution.Further examination of the patient's ipg site revealed a subcutaneous suture had opened.As a result, clear fluid and blood were observed at the ipg site.Next, the doctor re-sutured the wound and applied antibiotics to the incision.The patient's wound was re-sutured again after a floating stitch was later found.The patient will see an infectious disease physician to determine further treatment.

Event Description

Follow-up revealed the patient met with her doctor, but the date of the meeting is unknown at this time.The doctor cleaned/irrigated her wound and cauterized it more so that it could heal sufficiently.No signs of infection or pus were present.The patient will follow-up with her doctor to assess the wound.

Event Description

Follow-up revealed the doctor decided to explant the patient's scs system.Prior to explant, signs of redness and irritation were found at the ipg site but the doctor believes it was due to the patient experiencing an unspecified reaction.

• Brand Name: PROTÉGÉ MRI IPG
• 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: drew johnson ; 6901 preston rd; plano, TX 75024 ; 9725264667
• MDR Report Key: 5389595
• MDR Text Key: 36884027
• Report Number: 3006705815-2016-00028
• 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,Followup
• Report Date: 04/11/2016

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: 03/31/2017
• Device Model Number: 3771
• Device Lot Number: 5055447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2016; 03/18/2016; 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 39 YR