MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number	SC-2352-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Needle Stick/Puncture (2462)
Date of Event	01/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2352-50e, serial/lot: (b)(4), description: trial linear 3-4 lead, 50cm.
Event or Problem Description
A report was received that patient developed a severe headache one day after the trial procedure.The physician suspected the headache was due to a dural puncture caused during the insertion of the tuohey needle.The patient was treated with iv fluids, analgesia, a blood patch and bed rest.The patient was stable and released from the hospital.
Event or Problem Description
A report was received that patient developed a severe headache one day after the trial procedure.The physician suspected the headache was due to a dural puncture caused during the insertion of the tuohey needle.The patient was treated with iv fluids, analgesia, a blood patch and bed rest.The patient was stable and released from the hospital.

• Brand Name: PRECISION
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6341602
• Report Number: 3006630150-2017-00537
• Device Sequence Number: 16403167
• Product Code: LGW
• UDI-Device Identifier: 08714729789703
• UDI-Public: (01)08714729789703(17)180914(10)19699668
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

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: 09/14/2018
• Device Model Number: SC-2352-50E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 02/28/2017
• 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