MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6663
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient's ipg reach end of life.It is unknown if the ipg depleted prematurely.As a result, the ipg was replaced to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.An ipg reaching end of life was reported to abbott.The ipg was not returned for evaluation.Additionally, stimulation settings were are not available.In absence of complete stimulation parameters and settings, it is not possible to perform an accurate longevity calculation.Based on the information received, the ipg¿s longevity estimation could not be accurately determined and a single definitive root cause for the issue encountered was unable to be conclusively determined.The ipg was replaced to reestablish effective therapy.

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DBS IPG
• 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: 15514200
• Report Number: 1627487-2022-05116
• Device Sequence Number: 17652535
• Product Code: MHY
• UDI-Device Identifier: 05415067020277
• UDI-Public: 05415067020277
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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 Expiration Date: 05/23/2021
• Device Model Number: 6663
• Device Catalogue Number: 6663
• Device Lot Number: 7012777
• 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: 09/12/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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: Other
• Patient Sex: Female
• Patient Weight: 48 KG