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

Model Number	SC-1112
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Based on all available information, engineers concluded that the event of frequent charging of the ipg up to 3 to 4 hours a day while unsuccessfully achieving a full charge could not be confirmed through laboratory analysis of the device, as the device passed the functional test performed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that the patient was experiencing difficulty charging the implantable pulse generator ipg wherein requiring frequent charging up to 3 to 4 hours a day while unsuccessfully achieving a full charge.The impedances were measured and all contacts were functioning as normal.There were no hardware or software issues suspected with the ipg based on a review of the patients high frequency programming usage.The patients charger was replaced three times over the course of a 6 month period, however the issue continued.The patient underwent a revision procedure where the ipg was replaced.The patient was doing well post operatively.

• 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
• MDR Report Key: 12310500
• Report Number: 3006630150-2021-04453
• Device Sequence Number: 11716814
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 05/15/2019
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 20616400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention