MAUDE Adverse Event Report: PACEMAKER

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2015

Event Type  Injury  

Event Description

My mother and my father both rec'd pacemakers from boston scientific.The cardiac monitoring was done by latitude which is a defective service which does not work.I had a total of 3 monitors (confirmation #(b)(4)) for my mother, (b)(6) and none worked.Trouble shooting is a waste of time as the representatives at (b)(6) instructs you to unplug and plug the machine into the electric outlet and watch for the colorful light.I switched telephone companies and both indicated the phone line worked and that the monitoring service is the issue.My mother had multiple hospitalizations and i am fearful that since the company refused to fix the monitor service issue my mother is at great risk for major heart complications.Rx meds: latitude monitoring services from boston scientific, iron, folic acid, asa, potassium, aricept, metoprolol, tartrate, namenda, famotidine, atorvastatin.

• Brand Name: PACEMAKER
• Type of Device: PACEMAKER
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave n; st. paul, MN 55112 ; 6515827403
• MDR Report Key: 5001533
• MDR Text Key: 25241164
• Report Number: MW5055370
• Device Sequence Number: 0
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 50