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	Headache (1880); No Code Available (3191)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device involved: model #:sc-4220-45, lot # 23379761, description: entrada needle.A review of the manufacturing documentation for the entrada needles revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that during an implant procedure, the patient started to experience diurnal headaches.The patient was implanted without further problems.Several days later the patient did not show up for his programming session.The doctor was informed that the patient was hospitalized for the diurnal headaches and was given a blood patch.The cause of the headaches were due to the use of the entrada needle during the implant procedure and technique of the physician.

• 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: 9267169
• Report Number: 3006630150-2019-06141
• Device Sequence Number: 13968997
• 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): 11/01/2019

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 Date: 02/07/2020
• Device Model Number: SC-4220-45
• Device Catalogue Number: SC-4220-45
• Device Lot Number: 23298511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/01/2019
• 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