MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Sepsis (2067); Burning Sensation (2146); Fluid Discharge (2686)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported via social media that following an ipg replacement procedure (mfr.Report number: 3006630150-2021-04565), the patient had sepsis.The patient experienced pain and burning at the ipg site.It was noted that the ipg was overheating and fluid was seeping out.The patient had high fever and was sent to the emergency room (er).The patent underwent a spinal cord stimulator (scs) system explant procedure.No further information has been obtained despite good faith efforts.

• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12335682
• MDR Text Key: 267031596
• Report Number: 3006630150-2021-04567
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention