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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION
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BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number CC101018
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hypersensitivity/Allergic reaction (1907)
Date of Event 06/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient suffered a severe reaction at the site of needle entry after having a radiofrequency lumbar nerve ablation procedure.It is unknown if the patient was administered medical intervention.Boston scientific has been unable to obtain additional information to date despite good faith efforts.
 
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Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key12177922
Report Number3006630150-2021-03802
Device Sequence Number16983447
Product Code GXI
UDI-Device Identifier00813250012019
UDI-Public00813250012019
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K060799
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/15/2021
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
Operator of Device Lay User/Patient
Device Expiration Date12/03/2024
Device Model NumberCC101018
Device Catalogue NumberCC101018
Device Lot Number26462513
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/21/2021
Initial Report FDA Received Date07/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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