MAUDE Adverse Event Report: ABBOTT CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	1207-36
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During follow-up, oversensing due to noise was observed on the right ventricular (rv) lead.Diagnostic imaging was performed and revealed no anomalies.During the noise episodes the device began charging but stopped and did not deliver inappropriate high voltage therapy.The physician alleged a malfunction on the device.The device was then explanted and replaced due to normal eri and the rv lead was capped and replaced during this unrelated procedure.The patient was in stable condition.Related to manufacturer report number: 2938836-2019-03264.

• Brand Name: CURRENT VR RF
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8568534
• Report Number: 2938836-2019-03265
• Device Sequence Number: 1809782
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: 1207-36
• Device Lot Number: 2922689
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/01/2019
• 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: RIATA PASSIVE FIXATION