MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DVBB1D4

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.The returned device indicated shorting/low impedance in the battery.Hybrid analysis revealed that the device loss of telemetry and all functions were due to a severely depleted battery.The device was fully functional and operated under normal current drain when powered with an external supply.There was no evidence of a high current drain condition, and no hybrid anomalies were observed.Battery analysis revealed that the decrease in the voltage of battery was due to a cathode particle induced electrochemical short.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) was returned to the manufacturer after being removed for unknown reasons.  the device subsequently tested out of specification during the manufacturer¿s analysis.  no patient complications have been reported as a result of this event.

• Brand Name: EVERA¿ XT VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13122048
• MDR Text Key: 285048541
• Report Number: 3004209178-2021-19182
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169017948
• UDI-Public: 00643169017948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2015
• Device Model Number: DVBB1D4
• Device Catalogue Number: DVBB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6935M62 LEAD
• Patient Sex: Male