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	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced difficulty charging the implantable pulse generator (ipg).The patient had been using high rate stimulation settings.The patient was re-educated on proper charging techniques and a different charger was used to charge the ipg however neither of these troubleshooting attempts resolved the charging issue.Therefore, the patient underwent a successful ipg replacement procedure.The original leads remained implanted and there were no patient complications.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced difficulty charging the implantable pulse generator (ipg).The patient had been using high rate stimulation settings.The patient was re-educated on proper charging techniques and a different charger was used to charge the ipg however neither of these troubleshooting attempts resolved the charging issue.Therefore, the patient underwent a successful ipg replacement procedure.The original leads remained implanted and there were no patient complications.Additional information was reported that the patient did not have difficulty charging the ipg prior to the ipg replacement.It was clarified that the physician decided to replace the ipg only to upgrade the software.
Additional Manufacturer Narrative
Update to block b2 and h6: device codes.Block b3: approximated based on the date the manufacturer became aware of the event.

• 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: 16174422
• Report Number: 3006630150-2023-00051
• Device Sequence Number: 2303761
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 02/14/2023

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: 01/26/2018
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 18774747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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