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

Model Number 3667

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

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 (belgium) the patient did not put the ipg into surgery mode prior to surgery (date unknown).The ipg would no longer communicate with external devices postoperatively, and the patient lost stimulation.As a result, the physician explanted the ipg.

Manufacturer Narrative

The capa was initiated on 2016-02-23 to address the issue of the proclaim ipg entering service application.Investigation is complete and being monitored by the manufacturer.

Event Description

Follow up information identified monopolar device was utilized during the originally reported surgery where the ipg was not placed in surgery mode.The physician replaced the patient¿s ipg, and therapy has been restored.

• 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
• MDR Report Key: 7533728
• MDR Text Key: 108899953
• Report Number: 1627487-2018-05082
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: 3667
• Device Lot Number: 5597912
• Other Device ID Number: 05415067023254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other