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	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation after having the spinal cord stimulator (scs) system implanted for three years.The patient underwent a revision procedure to explant the device.No additional information was provided.

• 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: 15468494
• Report Number: 3006630150-2022-04942
• Device Sequence Number: 19902006
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: 08714729907114
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/18/2019
• Device Model Number: SC-1210B
• Device Catalogue Number: SC-1210B
• Device Lot Number: 308612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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
• Patient Age: 85 YR
• Patient Sex: Female