MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; IPG, 5.3 AH, DBS

Model Number	6660
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.(patient weight is unknown).
Event or Problem Description
It was reported the patient had her left dbs ipg replaced on (b)(6) 2022 because of unknown reasons.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the ipg was replaced due to end of life.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: IPG, 5.3 AH, DBS
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15983487
• Report Number: 1627487-2022-06813
• Device Sequence Number: 5724094
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: 05415067030016
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 5731519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DBS IPG (X1).; EXTENSIONS (X1).; EXTENSIONS (X1).; SCS ANCHOR (X1).; SCS ANCHOR (X1).; SCS LEAD (X1).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female