MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE; SCS IPG

Model Number 3660

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

The capa investigation was initiated on (b)(6) 2016 to address the issue of the proclaim ipg (orion ipg family).Investigation is complete and being monitored by the manufacturer.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported that the patient lost therapy following an unrelated surgery.As a result, the patient underwent surgical intervention to have their ipg replaced.Issue has been resolved.

Event Description

Additional information received indicated that prior to the ipg being replaced, the device was unable to communicate with external devices.Due to the inability of the ipg to communicate, it was explanted and replaced.

• Brand Name: PROCLAIM 5 ELITE
• Type of Device: SCS IPG
• 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
• Manufacturer Contact: toi milner-burk ; 9723098107
• MDR Report Key: 7519632
• MDR Text Key: 108439963
• Report Number: 1627487-2018-04902
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Model Number: 3660
• Device Lot Number: 6031798
• Other Device ID Number: 05415067020192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Treatment: MODEL 1192 SCS ANCHOR (2); MODEL 3186 SCS LEAD (2)
• Patient Outcome(s): Other
• Patient Age: 73 YR