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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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BOSTON SCIENTIFIC NEUROMODULATION Back to Search Results
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.

 
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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 Key12335682
MDR Text Key267031596
Report Number3006630150-2021-04567
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
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 Received08/18/2021
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
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 TREATMENT DATA
Date Received: 08/18/2021 Patient Sequence Number: 1
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