MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CROME¿ DR MRI SURESCAN¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDPC3D1
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Dyspnea (1816); Emotional Changes (1831)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported by the patient that their right ventricular (rv) lead was ¿frayed¿.The patient indicated that their previous implantable cardioverter defibrillator (icd) battery ¿exhausted because of the lead¿ and was explanted and replaced.The patient reported the rv lead was ¿already sucking up a lot of the battery¿ of the replacement icd.They noted that adjustments were made ¿so it doesn¿t suck up as much energy¿ but indicated that as a result of the programming changes ¿the pacemaker was not working as good as it should¿.The patient reported feeling short of breath and scared.The rv lead and replacement icd remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: CROME¿ DR MRI SURESCAN¿
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 19666952
• Report Number: 9614453-2024-02562
• Device Sequence Number: 12491137
• Product Code: LWS
• UDI-Device Identifier: 00763000178413
• UDI-Public: 00763000178413
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 12/28/2024
• Device Model Number: DDPC3D1
• Device Catalogue Number: DDPC3D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 07/11/2023
• 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: 694958 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male