MAUDE Adverse Event Report: MEDTRONIC, INC. ANALYZER SURGICAL CABLE; PROGRAMMER, PACEMAKER

Model Number 2292

Device Problems Failure to Sense (1559); Use of Device Problem (1670); Material Integrity Problem (2978); Output Problem (3005)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that that when attempting to test a lead there was no sensing or electrograms (egm) tracing.A different set of cables were used.It is anticipated that the cable will be returned for analysis.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis confirmed the customer comment that there was no sensing or electrogram (egm) tracing with the cable.It was noted that the ventricular negative connection was open and shorted to the ventricular positive connection, the ventricular negative pin was bent in the plug, that pin 24 was bent shorting to pin 25, the cable was contaminated, the cable tested that the ventricular positive and negative connections were shorted together, the negative connection was open, the positive connection was intermittent, the atrial connection tested ok and that there was correct resistance between pins 3 and 5.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the analyzer cable was received into service for analysis.

Manufacturer Narrative

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): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9787286
• MDR Text Key: 187221520
• Report Number: 2182208-2020-00431
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2292 ANALYZER CABLES(QTY 2), 5076 PACING LEAD(QTY2)
• Patient Age: 92 YR