MAUDE Adverse Event Report: ABBOTT SBP DR INDUCTIVE PACEMAKER, JPD; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2152

Device Problem No Pacing (3268)

Patient Problems Arrhythmia (1721); Respiratory Failure (2484)

Event Date 07/29/2022

Event Type  Death  

Event Description

The patient presented to the emergency department in poor general health.No pacing output was noted on the ecg.Interrogation was not possible as the facility did not have a merlin programmer in their possession.The patient declined the use of any external pacing therapy or other therapeutic or surgical intervention.The patient had multiple comorbidities, and a do not resuscitate (dnr) status, and passed away due to bradycardia and respiratory distress, on the same day.The device will not return for analysis as it remains in the patient.The previous follow up in (b)(6) 2021 did not reveal any device anomalies.The patient was not enrolled or monitored regularly on merlin.Net.The physician reported a malfunction of the device contributed to the death of the patient.

• Brand Name: SBP DR INDUCTIVE PACEMAKER, JPD
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15466396
• MDR Text Key: 300398889
• Report Number: 2017865-2022-37583
• Device Sequence Number: 1
• Product Code: NVZ
• 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,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PM2152
• Device Lot Number: P000090963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2019
• 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): Death