MAUDE Adverse Event Report: ABBOTT IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5180
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.Investigation results will be provided in the final report.
Event or Problem Description
During a follow-up in clinic, the device was unable to be interrogated.The device was explanted and replaced and the patient was stable with no consequences.
Additional Manufacturer Narrative
It was reported the device could not be interrogated.The physician believed the device was either at end of life (eol) or there was a malfunction.Analysis for this product is unable to be completed as the product is could not to be located.The device projected longevity was calculated based on nominal settings.Projected longevity was 7.31 years and approximate implant duration was 9.30 years, which exceeded projected longevity and is considered normal battery depletion.The interrogation anomaly reported from the field is considered normal as the device exceeded projected longevity and the battery depleted in normal and expected manner.Should the device be located, analysis will be performed, as applicable.

• Brand Name: IDENTITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8569304
• Report Number: 2017865-2019-06299
• Device Sequence Number: 1809805
• Product Code: LWP
• UDI-Device Identifier: 05414734006804
• UDI-Public: 05414734006804
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 12/31/2009
• Device Model Number: 5180
• Device Lot Number: 2923022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention