MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number	6660
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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 patient's ipg value showed as abnormal.Surgical intervention may occur to address the issue.
Event or Problem Description
Additional information received indicates that the ipg was explanted and replaced.
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.
Additional Manufacturer Narrative
The reported observation of ¿after 22 days, value showed abnormal¿ was confirmed.The root cause of the reported observation was due to the device having a degradation within the eppic ic (u1), which resulted in the device drawing higher current than normal and causing premature battery depletion.The device was subjected to ate testing and passed all test steps.A review of the ate fuel gauge test step showed a higher than normal calculated stimulation off battery current of.666ma.The device was fully functional as received but exhibited a higher-than-normal current consumption.A review of the ipg diagnostic logs showed the device was depleting at a higher rate.The dhr review had determined that manufacturing completed all steps correctly and there were no errors in the production of the product.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DRG 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: 15422660
• Report Number: 1627487-2022-05031
• Device Sequence Number: 11949454
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: 05415067030016
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00000428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 05/01/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/05/2022; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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: Other
• Patient Sex: Unknown