MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2240

Device Problems Failure to Transmit Record (1521); Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Head Injury (1879); Concussion (2192); Loss of consciousness (2418)

Event Date 04/12/2021

Event Type  Injury  

Event Description

I had a st jude pacemaker which was implanted on (b)(6) 2017.While i was in my office at work on (b)(6) 2021, i passed out, hit my head and was later told by a doctor that i had experienced a concussion.I went to my family doctor, (b)(6) who had several tests performed which were inconclusive.I went to (b)(6) where it was determined that my pacemaker was apparently too weak to transmit data for readings and had not transmitted data since (b)(6) of last year i believe.My pacemaker was supposed to have been monitored by my cardiologist, dr.(b)(6) however i was never notified that the pacemaker was either weak or that they were not receiving transmissions of data from my pacemaker.I visited dr.(b)(6) 2021 and he scheduled a pacemaker replacement the following morning.I had my pacemaker replaced at (b)(6) 2021.My second pacemaker lasted less than four years while my original pacemaker lasted approximately ten years.I have found information online which indicates that abbott which owns st.Jude has issued a safety notification on march 15th 2021 which indicates that a number of customers have experienced reduced battery longevity along with other issues due to a manufacturing process which involved an incomplete mixing of epoxy during manufacture, which may allow moisture ingress into the pulse generator header.Fda safety report id # (b)(4).

• Brand Name: ST. JUDE PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 11847981
• MDR Text Key: 251733334
• Report Number: MW5101413
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 05/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 56