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

Model Number	DB-7164
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block b3: date of event - approximately one month before the manufacturer became aware of the event on 22jun2025.Exact date is unknown.
Event or Problem Description
It was reported by the neurologist that their clinician programmer (cp) crashed and his facility was unable to manage the patient's implanted with deep brain stimulation (dbs) implantable pulse generators (ipg).Several emergencies have come up without the ability to optimize programming for the patients.The physician believes that the interruption in care has significantly impacted the patient's functional status due to the delay in programming optimization.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, lgw, pjs, mhy, qrb.
Event or Problem Description
It was reported by the neurologist that their clinician programmer (cp) crashed, and his facility was unable to manage the patient's implanted with deep brain stimulation (dbs) implantable pulse generators (ipg).Several emergencies have come up without the ability to optimize programming for the patients.The physician believes that the interruption in care has significantly impacted the patient's functional status due to the delay in programming optimization.Additional information was received from the physician that the use of the dbs cp was for patients that require unique therapy programming optimization.While attempting to program the therapy for a patient all of the database information was accidentally deleted from the cp, including all brainlab imaging data.The physician then requested an upgrade for the cp software, and it took about one month to send a replacement cp to the physician.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22800923
• Report Number: 3006630150-2025-06483
• Device Sequence Number: 15403400
• Product Code: MHY
• UDI-Device Identifier: 08714729991281
• UDI-Public: (01)08714729991281(10)29406198
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: Health Professional
• Device Model Number: DB-7164
• Device Catalogue Number: DB-7164
• Device Lot Number: 29406198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown