MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA S DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDBC3D1
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Bradycardia (1751); Stroke/CVA (1770); Dyspnea (1816); Muscle Weakness/Atrophy (1967); Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/05/2021
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 the patient experienced heart failure with shortness of breath, weakness, and possible stroke was suspected.There was intermittent undersensing causing false termination of some atrial tachycardia/atrial fibrillation (at/af) episodes.Additionally, it was noted the patient's heart was in the 20's to 30's and was below the implantable cardioverter defibrillator's (icd) programmed lower rate.The right atrial (ra) lead and icd remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA S DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11208170
• Report Number: 3004209178-2021-01126
• Device Sequence Number: 3372455
• Product Code: LWS
• UDI-Device Identifier: 00643169530287
• UDI-Public: 00643169530287
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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: Lay User/Patient
• Device Expiration Date: 07/14/2018
• Device Model Number: DDBC3D1
• Device Catalogue Number: DDBC3D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/21/2021
• 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: 694765 LEAD, 407652 LEAD.
• Patient Age: 85 YR
• Patient Weight: 91