MAUDE Adverse Event Report: UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6721M-50
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4968-35, lead, implanted: (b)(6) 2009 and 5076-52, lead, dtba1d1, crt-d, 694765, lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was a suspected lead issue with the epicardial right ventricular (rv) lead/patch as there was a spike to undefined high rv coil impedance and a fracture was possible.The superior vena cava (svc) coil of the other rv lead had a spike to undefined high impedances and a fracture was noted to be possible.In addition, there was variable impedance noted for both leads.The epicardial rv lead/patch was capped.The rv lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was variable.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: UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• MDR Report Key: 12100521
• Report Number: 2182208-2021-02667
• Device Sequence Number: 3965950
• Product Code: LWS
• UDI-Device Identifier: 00681490148771
• UDI-Public: 00681490148771
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2011
• Device Model Number: 6721M-50
• Device Catalogue Number: 6721M-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: 1888TC-52 LEAD; 1888TC-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR