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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-4220-45.Batch/lot number: 21809062.Model/catalog description: 4.5 inch entrada 2.0 needle.The devices were not returned to bsn as they were discarded by the medical facility.
Event or Problem Description
A report was received that during a perm implant the patient had a cerebrospinal fluid leakage (csf leak) on both needle placements.The physician was not able to put in the lead due to csf leak.The physician did a blood patch and it was unknown if there was any other medication given.The case was aborted.
Additional Manufacturer Narrative
Model number/catalog number: sc-4220-45; batch/lot number: 21809062; model/catalog description: 4.5 inch entrada 2.0 needle.The devices were not returned to bsn as they were discarded by the medical facility.Additional information was received that the patient was not experiencing any after effects and was reportedly doing well.
Event or Problem Description
A report was received that during a perm implant the patient had a cerebrospinal fluid leakage (csf leak) on both needle placements.The physician was not able to put in the lead due to csf leak.The physician did a blood patch and it was unknown if there was any other medication given.The case was aborted.

• 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: 7679390
• Report Number: 3006630150-2018-60108
• Device Sequence Number: 16355801
• Product Code: LGW
• UDI-Device Identifier: 08714729950684
• UDI-Public: 08714729950684
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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 Date: 12/25/2018
• Device Model Number: SC-4220-45
• Device Catalogue Number: SC-4220-45
• Device Lot Number: 21805757
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: Required Intervention
• Patient Age: 67 YR