MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number MC1VR01US

Device Problems Battery Problem (2885); Missing Test Results (3267)

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

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to use of a leadless implantable pulse generator (ipg) there was low battery voltage and an observation for ¿remaining longevity is not available, potentially due to cold temperature" upon interrogation.It was noted the device was interrogated again five days later and the battery voltage further fallen.The ipg was not utilized.There was no patient involvement.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Hybrid analysis confirmed the low battery voltage failure.The hybrid was fully functional with nominal pacing output, and normal current drain.Since no failure mode was present, the cause of the low battery voltage was not determined.Computed tomography scanning revealed an anomaly at the battery electrical connector weld as the interface was notably different on the suspect device as compared to a reference device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.The returned device indicated an issue with the battery.Hybrid analysis confirmed the low battery voltage failure.The hybrid was fully functional with nominal pacing output, and normal current drain.Since no failure mode was present, the cause of the low battery voltage was not determined.Battery analysis found the battery had high internal resistance.Electrical testing and destructive analysis indicated the battery was exposed to a high current drain (up to and including a direct short) which caused the high internal resistance condition.No evidence of an internal mechanism for premature depletion (or causing low voltage prior to implant) was found during destructive analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.The returned device indicated an issue with the battery.Hybrid analysis confirmed the low battery voltage failure.The hybrid was fully functional with nominal pacing output, and normal current drain.Since no failure mode was present, the cause of the low battery voltage was not determined.Battery analysis found the battery had high internal resistance.Electrical testing and destructive analysis indicated the battery was exposed to a high current drain (up to and including a direct short) which caused the high internal resistance condition.No evidence of an internal mechanism for premature depletion (or causing low voltage prior to implant) was found during destructive analysis.The analysis finding code (afc) is coded in accordance with document r193677 and is attached to this record.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: MICRA
• Type of Device: LEADLESS PACEMAKER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8845689
• MDR Text Key: 152781220
• Report Number: 9612164-2019-03141
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 00643169711761
• UDI-Public: 00643169711761
• Combination Product (y/n): N
• PMA/PMN Number: P150033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2020
• Device Model Number: MC1VR01US
• Device Catalogue Number: MC1VR01US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1