MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO EVERA¿ S DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDBC3D4
Medical Device Problem Codes	Mechanical Problem (1384); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a planned device changeout procedure that the wrench was unable to activate the setscrew, unable to get into screw as the screw was misaligned and sideways in header.  the setscrew threads were damaged or stripped and could not turn.The doctor had to cut the silicone to remove the screw and then pull lead out from header.The implantable cardioverter defibrillator (icd) was explanted and replaced. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.Visual analysis of the returned product showed the right ventricular (rv) grommet was found with damage, the rv setscrew is missing and the rv connector block was found with damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVERA¿ S DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19157692
• Report Number: 3004209178-2024-09541
• Device Sequence Number: 18011913
• Product Code: LWS
• UDI-Device Identifier: 00643169018020
• UDI-Public: 00643169018020
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: Lay User/Patient
• Device Expiration Date: 05/14/2015
• Device Model Number: DDBC3D4
• Device Catalogue Number: DDBC3D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-45 LEAD, 6935M55 LEAD
• Patient Age: 66 YR
• Patient Sex: Male