MAUDE Adverse Event Report: COV LP/LLC, AUGUSTA ANALYZER SURGICAL CABLE; PROGRAMMER, PACEMAKER

Model Number 2292

Device Problem Material Integrity Problem (2978)

Patient Problem Cardiac Arrest (1762)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an implant procedure the patient cable was attached to the newly implanted right ventricular (rv) lead via alligator clip when the patient became asystolic.The patient was attempted to be paced from the programmer software analyzer (psa) but failed.The patient had to be subcutaneously paced until the cable was changed out.The reported cable was discarded by the facility.It was noted that the cable had been resterilized but that it was not possible to determine how many times it had been resterilized.There were no further patient complications reported as a result of this event and it was noted that the patient was ¿alive with no injury.¿ it was further reported that the physician assessed that the patient becoming asystolic was not caused by the cable but by patient condition alone, the cable had been inspected prior to use with no issues note.

• Brand Name: ANALYZER SURGICAL CABLE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10164160
• MDR Text Key: 195449094
• Report Number: 1018120-2020-00004
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Device Lot Number: 2292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/17/2020
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention