MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-4220-45
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880); Pain (1994); No Code Available (3191)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a cerebral spinal fluid leak during a previous revision procedure.The physician was able to use surgical glue to repair the puncture.The patient was doing fine post-operatively but did develop a headache and intense pain.The patient was hospitalized for two days for the dura puncture.The device was not returned to bsn as it was discarded.

• 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 Key: 10392094
• Report Number: 3006630150-2020-03360
• Device Sequence Number: 11193958
• Product Code: LGW
• UDI-Device Identifier: 08714729950684
• UDI-Public: 08714729950684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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 Date: 08/28/2020
• Device Model Number: SC-4220-45
• Device Catalogue Number: SC-4220-45
• Device Lot Number: 24326137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention