MAUDE Adverse Event Report: ABBOTT FORMERLY ST JUDE MEDICAL IMPLANTABLE CARDIAC PACEMAKER

Model Number P/G PM2210

Device Problem Device Inoperable (1663)

Patient Problems Cardiac Arrest (1762); Death (1802); Pain (1994); Ventricular Flutter (2131); Pressure Sores (2326); Weight Changes (2607)

Event Date 11/10/2015

Event Type  Death  

Event Description

Reporter filing report on behalf of late mother.On (b)(6) 2015, my mother was rushed to the hospital due to her heart rate fluttering.She had pain from sores around pacemaker site and her weight had fluctuated drastically.Reporter believes the pacemaker stopped working and caused his mother's cardiac arrest that led to her passing on (b)(6) 2015.Reporter also has concerns regarding cyber security vulnerabilities especially with the hacking incident that occurred recently and hopes his mother's hospital records and records from pacemaker have not been lost.

• Brand Name: IMPLANTABLE CARDIAC PACEMAKER
• Type of Device: IMPLANTABLE CARDIAC PACEMAKER
• Manufacturer (Section D): ABBOTT FORMERLY ST JUDE MEDICAL
• MDR Report Key: 6843002
• MDR Text Key: 84988659
• Report Number: MW5071933
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P/G PM2210
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 75 YR
• Patient Weight: 66