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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-4220-45
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 09/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect device: model sc-4220-45.Description 4.5 inch entrada 2.0 needle.Lot number 24107711.
 
Event or Problem Description
A report was received that during a permanent implant procedure the patient experienced a dural puncture resulting in a significant loss of spinal fluid.A blood patch was administered and the procedure was aborted.The patient is recovering, and the event resolved the same day.The physician assessed that the non-serious adverse event was procedure related and not device or stimulation related.
 
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Brand Name
ENTRADA
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9218952
Report Number3006630150-2019-05917
Device Sequence Number2352101
Product Code LGW
UDI-Device Identifier08714729950684
UDI-Public08714729950684
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/22/2019
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 Health Professional
Device Expiration Date07/19/2020
Device Model NumberSC-4220-45
Device Catalogue NumberSC-4220-45
Device Lot Number24107711
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/22/2019
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 Required Intervention;
Patient Age79 YR
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