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

Model Number	2292
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when performing detection tests for implanted leads using the analyzer surgical cable with the programmer it was observed that when connecting only the atrium pins (blue pins) in the lead, the programmer showed the detection value in the ventricle section and when connecting only the ventricle pins (white pins) in the lead, the programmer showed the detection value in the atrium section.It was noted that the analyzer surgical cable was switched out for a different cable which resolved the issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: analysis could not confirm the customer's comment that there was an issue with the analyzer surgical cable as the cable passed all visual inspection and bench testing with no anomalies observed.Visual inspection found no issues and all continuity tests were ok.Correct resistance was found between pins 3 and 5 and no intermittent or shorted connections found.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.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
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 12376599
• Report Number: 2182208-2021-03382
• Device Sequence Number: 17301488
• Product Code: KRG
• UDI-Device Identifier: 00643169703247
• UDI-Public: 00643169703247
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Device Lot Number: 752470001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2090 PROGRAMMER.; 2090 PROGRAMMER