MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-9218-15
Medical Device Problem Codes	Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-adapters, upn: m365sc9218150, model: sc-9218-15, serial: (b)(6), batch: 7074421.Product family: dbs-adapters, upn: m365db9218550, model: db-9218-55, serial: (b)(6), batch: 7062233.Product family: scs-ipg-r, upn: m365sc11600, model: sc-1160, serial: (b)(6), batch: 367592.
Event or Problem Description
It was reported that the patient experienced undesired sensations in their head related to stimulation.The patient underwent a procedure (reported in mfr# 3006630150-2023-01540) to revise the spinal cord stimulation (scs) system in response to the undesired sensations.However, the patient continued to experience these sensations postoperatively, and underwent a second procedure.Prior to the second procedure the physician was unable to connect to the implantable pulse generator (ipg) since the device had been off since the previous procedure; pre-operative charging efforts in the hospital were unsuccessful.Therefore, the ipg and non-boston scientific leads were replaced, and the lead adapters were removed.The patient did well postoperatively and received adequate coverage.Physical analysis of the devices could not be completed in our laboratory, as they were discarded by the facility.

• Brand Name: PRECISION
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17761363
• Report Number: 3006630150-2023-05590
• Device Sequence Number: 6618760
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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: 09/22/2024
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 7074801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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 Sex: Unknown