MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION Precision Montage ¿ MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1210B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Sepsis (2067)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the wife of the patient that the patient experienced sepsis three times in 2018.While the patient had been waiting to have surgery to remove the spinal cord stimulator, the patient had been hospitalized.The patient did then have the spinal cord stimulator explanted and it was found that the sepsis had been in the spinal cord stimulator.During the time that the patient was hospitalized the patient became partially paralyzed and by the time the explant surgery was completed he was paralyzed from the chest down.The wife of the patient noted that the implanting physician assessed the device was not the cause of the reported events.The patient underwent rehabilitation which was unsuccessful and then was placed in a long term care facility.The location of the explanted device is unknown.

• Brand Name: Precision Montage ¿ MRI
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15353114
• Report Number: 3006630150-2022-04497
• Device Sequence Number: 6049287
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: 08714729907114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: 08/29/2019
• Device Model Number: SC-1210B
• Device Catalogue Number: SC-1210B
• Device Lot Number: 307927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male