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

Model Number	DDBC3D4
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5086mri45 lead, implanted on (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient¿s right ventricular (rv) lead triggered an alert for a pacing impedance reading of zero.In addition, the rv lead was exhibiting sensing integrity counter (sic) that started abruptly and increased daily.The rv lead was capped and replaced.It was further reported that the physician thought the impedance and sic issues could be related to the patient¿s implantable cardioverter defibrillator (icd).The 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 not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• 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: 7945095
• Report Number: 3004209178-2018-22551
• Device Sequence Number: 770134
• Product Code: LWS
• UDI-Device Identifier: 00643169530294
• UDI-Public: 00643169530294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019

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: 10/14/2018
• Device Model Number: DDBC3D4
• Device Catalogue Number: DDBC3D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 01/24/2019
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/18/2018; 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR