MAUDE Adverse Event Report: ST JUDE/ ABBOTT MEDICAL ASSURITY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number PM2272

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Cognitive Changes (2551)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Fh kolbe symptoms: 1.Exhaustion and lack of energy-on waking up in morning full of energy but as soon as out of bed energy disappears and head becomes fussy.2.Fussy/foggy head with confusion.Distracted and slow thinking and bad short term memory, irritated.3.Clumsiness and occasional shaking under stress.4.Legs exhausted and stiff-feel as though they are puffy.5.Feet puffy.6.Breathlessness even though oximeter blood oxygen remains in range of 96 to 99%.Throat tight, stomach restricting diaphragm.Nebulising with duolin (morning and evening) has all but eliminated wheezing in throat.7.Blood pressure generally 150 to 165 systolic, 75 to 100 diastolic.When systolic less, diastolic exceeds 60, symptoms worse.Safety report id # (b)(4).

• Brand Name: ASSURITY PACEMAKER
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): ST JUDE/ ABBOTT MEDICAL
• MDR Report Key: 15856349
• MDR Text Key: 304332875
• Report Number: MW5113456
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ELIQUIST, PANADO, OXIMETER, NEBULIZER, DUOLIN.; MULTI VITAMIN, VITAMIN A VITAMIN D.
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White