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

Model Number	SC-1112
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown.
Event or Problem Description
It was reported that two days following hip surgery the patient could not feel stimulation and the remote could not communicate with the ipg.The physician suspects electrocautery was used during the hip surgery.The patient underwent a revision procedure to replace the ipg and therapy was restored.
Additional Manufacturer Narrative
The returned precision ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.The physician suspected the reported loss of stimulation was due to electrocautery used in a non-device related surgery; however, device analysis revealed the ipg to be in hibernation mode, able to be fully charged, and working properly.
Event or Problem Description
It was reported that two days following hip surgery the patient could not feel stimulation and the remote could not communicate with the ipg.The physician suspected electrocautery was used during the hip surgery, but was not able to confirm.The patient underwent a revision procedure to replace the ipg and therapy was restored.

• 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: 11312117
• Report Number: 3006630150-2021-00416
• Device Sequence Number: 883749
• 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: 2018
• 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,Followup
• Report Date (Section B): 03/11/2021

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: 01/22/2020
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 21606592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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