MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1160
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Capturing Problem (2891)
Health Effect - Clinical Codes	Arrhythmia (1721); Discomfort (2330)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented in-clinic reporting bradycardia episodes.Upon examination, the patient's pacemaker was unable to be interrogated.An unspecified capture issue was suspected due to the patient's bradycardia symptom.The pacemaker was explanted and replaced on (b)(6) 2021.The patient was stable throughout the intervention process and no additional patient consequences were reported.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
New information received notes that premature battery depletion was alleged on the pacemaker and the failure to interrogate was a failure of inductive telemetry.Additionally, the patient reported general discomfort when presenting in-clinic.
Additional Manufacturer Narrative
The reported events of premature discharge of battery, failure to interrogate and capturing problem were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and the battery was found depleted.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, depleting the battery prematurely.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: ENDURITY SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12813925
• Report Number: 2017865-2021-36715
• Device Sequence Number: 17529870
• Product Code: NVZ
• UDI-Device Identifier: 05414734507042
• UDI-Public: 05414734507042
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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: 03/31/2018
• Device Model Number: PM1160
• Device Catalogue Number: PM1160
• Device Lot Number: A000029627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 01/31/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/10/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1531-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown