MAUDE Adverse Event Report: Biotronik Prospera IPG; Implantable pulse generator

Model Number	457849
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury

• Brand Name: Prospera IPG
• Common Device Name: Implantable pulse generator
• Manufacturer (Section D): Biotronik; 6024 jean road; lake oswego OR 97035
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; +1(877)245-9800
• MDR Report Key: 50740072
• Report Number: 3027063190-2026-00353
• Device Sequence Number: 16098810
• Product Code: LGW
• UDI-Device Identifier: 04035479170110
• UDI-Public: (01)04035479170110(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P210037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 457849
• Device Catalogue Number: 457849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown