MAUDE Adverse Event Report: ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; implantable pacemaker Pulse-generator

Model Number PM2162

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  Injury  

Event Description

During follow-up, the device was interrogated and battery depletion was normal.The physician then ended the interrogation session but noted the implant date was not entered.The physician then interrogated the device again and programmed the implant date.The physician then observed excessive battery consumption and decreased device longevity.The patient was then hospitalized.Additional interrogation of the device was performed and no change was observed.A magnet was then applied and current battery consumption and device longevity were normal.The physician alleged a malfunction on the device.Abbott technical support was contacted and review of the session records indicated this event was due to incomplete clearing of the diagnostics.No additional intervention is required as the event will be resolved on it's own.No malfunction is suspected.The patient was in stable condition and experienced no adverse health consequences.

• Brand Name: ENDURITY PACEMAKER, DR, MRI RESTRICTED
• Type of Device: implantable pacemaker Pulse-generator
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18846846
• MDR Text Key: 337007754
• Report Number: 2017865-2024-34252
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2162
• Device Lot Number: P000169744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization