MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; 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	Stroke/CVA (1770); Paralysis (1997)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-2366-50e, serial #: (b)(4), description: trial linear 3-6 lead, 50cm.
Event or Problem Description
A report was received that the during the trial procedure the patient suffered a stroke and was in the intensive care unit.The physician did not believe it was due to the device.The patient will undergo a lead pull.No device malfunction was suspected.
Additional Manufacturer Narrative
Additional information was received that the patient had right sided paralysis due to stroke.No further course of action at this time.
Event or Problem Description
A report was received that the during the trial procedure the patient suffered a stroke and was in the intensive care unit.The physician did not believe it was due to the device.The patient will undergo a lead pull.No device malfunction was suspected.

• Brand Name: PRECISION MONTAGE MRI
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7447027
• Report Number: 3006630150-2018-01384
• Device Sequence Number: 16448218
• Product Code: LGW
• UDI-Device Identifier: 08714729789703
• UDI-Public: 08714729789703
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 07/29/2019
• Device Model Number: SC-2352-50E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR