MAUDE Adverse Event Report: ST JUDE MEDICAL / ABBOTT MEDICAL ENDURITY CORE DUAL CHAMBER PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2152

Device Problems Pacing Problem (1439); Application Program Problem: Parameter Calculation Error (1449); Material Integrity Problem (2978)

Patient Problems Bradycardia (1751); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Vomiting (2144)

Event Date 05/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2022 my cardiologist implanted a pacemaker because i had a complete electrical blockage to my left ventricle (lbbb) and my pulse had fallen to 35.On (b)(6) 2023, after only 14 months of usage, my pulse suddenly dropped to 44.My cardiologist performed a 24 hour holter test and determined that the pacemaker was not functioning.The device is st jude, endurity core dual chamber.Model pm2152, serial number (b)(6).The leads are: cpt175284 and cpt178937.On (b)(6) 2023 the surgeon accessed the st jude device and repositioned the ventricular lead.I was discharged from the hospital.On (b)(6) 2023 my pulse fell to 33 or lower so rushed to the hospital.I was treated there for about 7 hours and the on-duty-cardiologist told me that i must travel to a larger hospital 6 hours away or i would die within 24 hours.We took an ambulance for the 6-hour ride and arrived at (b)(6) at approximately 11:00 am.My cardiologist and surgeon were waiting in the er (emergency room).At this time my pulse was in the 20's and i was vomiting blood.I was taken to the operating room and the surgeon determined that the lead to the ventricle was not working and was likely damaged.It was removed and a new one inserted.Two days later my pulse again fell and we visited the er again.The st.Jude representative started testing me, and called in an electrophysiologist.They determined that my st jude pacemaker was now requiring 3 volts instead of 1 so they reprogrammed the device.My heart rate is now stabilized at 75 bpm.However, i am told that the increased level of voltage will shorten the battery life of the device to approximately 6 years instead of 9-10, and i am concerned that this might all happen again.As a side note, i was forced to pay cash to st jude for the new lead installed by the surgeon.The cardiologist told me he was certain the lead somehow was damaged and urged the st jude rep to send it in to be analyzed.I am told this will take 6 months.Reference reports: mw5118515, mw5118516.

• Brand Name: ENDURITY CORE DUAL CHAMBER PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST JUDE MEDICAL / ABBOTT MEDICAL
• MDR Report Key: 17182751
• MDR Text Key: 317791670
• Report Number: MW5118514
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2023

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
• Device Model Number: PM2152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Patient Sequence Number: 1
• Treatment: MULTI VITAMIN, PATANOL FOR ITCHY EYES.; TRELEGY FOR COPD, HYDROCHLOROTHIAZIDE, CRESTOR, HOLTER MONITOR, ENDURITY CORE LEAD CPT175284, ENDURITY CORE LEAD CPT178937.
• Patient Outcome(s): Other; Hospitalization; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White