MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334VRG
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
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 indicated the lead impedance data was missing/invalid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was an unknown issue with the implantable cardioverter defibrillator (icd) that made the right ventricular (rv) pacing impedance reading equal zero.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA VR
• 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
• MDR Report Key: 10830259
• Report Number: 3004209178-2020-19876
• Device Sequence Number: 17166051
• Product Code: LWS
• UDI-Device Identifier: 00613994677846
• UDI-Public: 00613994677846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 11/28/2013
• Device Model Number: D334VRG
• Device Catalogue Number: D334VRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR