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

Model Number	SC-1112
Medical Device Problem Codes	Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the cause of the patient experiencing difficulty charging of the ipg and undergoing an ipg replacement procedure was not confirmed based on device analysis and record review.Device technical analysis: the ipg was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information, engineers are not able to confirm the root cause of the event.The ipg was returned, as such, physical analysis was conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint as no problem was detected.
Event or Problem Description
It was reported that the patient experienced difficulty charging and underwent a procedure in which the implantable pulse generator (ipg) was replaced.The patient is doing well post operatively.
Event or Problem Description
It was reported that the patient experienced difficulty charging and underwent a procedure in which the implantable pulse generator (ipg) was explanted.The patient is doing well post operatively.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Investigation summary: with all the available information, boston scientific concludes that the cause of the patient experiencing difficulty charging of the ipg and undergoing an ipg replacement procedure was not confirmed based on device analysis and record review.Device technical analysis: the ipg was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information, engineers are not able to confirm the root cause of the event.The ipg was returned, as such, physical analysis was conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint as no problem was detected.
Event or Problem Description
It was reported that the patient experienced difficulty charging and underwent a procedure in which the implantable pulse generator (ipg) was explanted.The patient is doing well post operatively.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Investigation summary: with all the available information, boston scientific concludes that the cause of the patient experiencing difficulty charging of the ipg and undergoing an ipg replacement procedure was not confirmed based on device analysis and record review.Device technical analysis: the ipg was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information, engineers are not able to confirm the root cause of the event.The ipg was returned, as such, physical analysis was conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint as no problem was detected.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17347532
• Report Number: 3006630150-2023-04201
• Device Sequence Number: 6091479
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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: 08/24/2018
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 19629859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 07/27/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 07/25/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2016
• 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