MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL KAPPA DDDR 900; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number KDR901

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problem Chest Pain (1776)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient stated they are experienced "weird symptoms like pacing irregular & skip a few beats & then beats close together"."feels something moving"."feel device atrial pace" and chest pain.The patient also reported that "they are seeing noise".The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: KAPPA DDDR 900
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11185077
• MDR Text Key: 228887742
• Report Number: 2647346-2021-00004
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2003
• Device Model Number: KDR901
• Device Catalogue Number: KDR901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/18/2021
• Date Device Manufactured: 05/08/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR