MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Precision? Montage? MRI; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-1200
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Delayed Charge Time (2586); Charging Problem (2892)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was having difficulty charging the implantable pulse generator (ipg) and the patient's spinal cord stimulator (scs) paddle lead had migrated.It was also stated that the patient was not getting the right coverage despite device optimization.The patient underwent a procedure wherein the ipg and lead were explanted.
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: model number/catalog number: sc-2317-70.Serial number: (b)(6).Batch/lot number: 5117541.Model/catalog description: infinion cx lead kit, 70cm.Unique identifier (udi)#: (b)(4).

• Brand Name: Precision? Montage? MRI
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50851700
• Report Number: 3006630150-2026-06988
• Device Sequence Number: 10025724
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 11/21/2020
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 359169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female