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

Model Number 2292

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Operating System Becomes Nonfunctional (2996)

Patient Problems Cardiac Arrest (1762); Injury (2348)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient is pacemaker dependent, during the procedure whilst using the analysers surgical cable, transmission was lost between the analyzer and the implanted electrode.The procedure was completed using a different device.Hospitalisation and intervention was required as a result of this event.The cable will be returned to service and repair.Injury reported.It was further reported the programmer was used the following day with no issues reported.The programmer will be returned to service and repair to be tested with the cable.

Manufacturer Narrative

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

Event Description

It was further reported there was a sudden loss of stimulation, no peaks were visible on the monitor, connection and the lead position was checked, cardiac massage during asystole.After change to another programmer and another measuring cable regular stimulation took place again.It was further reported the analyser was returned to service and repair.

Manufacturer Narrative

Product analysis: the analysis could not confirm the customer comment.During a bench test the plug came loose from the analyzer connector after tension was applied , however this did not result in any failure or loss of connection.The analyzer and cable passed functional and bench tests with no failures or problems observed.The programmer passed electrical safety test with the analyser cable.It was identified at analysis that the analyzer locking latch was broken.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANALYZER SURGICAL CABLE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 10032129
• MDR Text Key: 190111455
• Report Number: 1018120-2020-00003
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 04/20/2020; 07/03/2020
• Supplement Dates FDA Received: 05/15/2020; 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2090 PROGRAMMER; 2090 PROGRAMMER
• Patient Outcome(s): Hospitalization; Required Intervention