MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION 5IN INSERTION NEEDLE; SPINAL CORD STIMULATOR

Model Number	SC-4205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that during the patient¿s trial implant procedure the physician noted a cerebrospinal fluid (csf) leakage caused when attempting to access the epidural space.The patient was treated with iv fluids.Following the procedure, the patient reported a headache.The physician decided to place a blood patch to address the patient¿s headache and the patient is reportedly stable following the treatment.
Event or Problem Description
A report was received that during the patient¿s trial implant procedure the physician noted a cerebrospinal fluid (csf) leakage caused when attempting to access the epidural space.The patient was treated with iv fluids.Following the procedure, the patient reported a headache.The physician decided to place a blood patch to address the patient¿s headache and the patient is reportedly stable following the treatment.

• Brand Name: 5IN INSERTION NEEDLE
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7496860
• Report Number: 3006630150-2018-01619
• Device Sequence Number: 10822588
• Product Code: LGW
• UDI-Device Identifier: 08714729121459
• UDI-Public: 08714729121459
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 07/18/2019
• Device Model Number: SC-4205
• Device Lot Number: 20882715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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