MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA¿ S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTBB1D4
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 6935m62 lead.Implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to healthcare facility for evaluation due to complaints of diaphragmatic stimulation thought to be due to pacing.The patient symptoms have been intermittent for approximately six and a half months.The patient believes the diaphragmatic stimulation is positional, and is very annoying but not painful.Upon interrogation of the associated cardiac resynchronization therapy defibrillator (crt-d), with the encore programmer, interrogation fails at twenty percent.Multiple attempts to interrogate the crt-d result in same outcome.It was also reported that the patient has a non medtronic left ventricular assist device (lvad), that gives off enough electromagnetic interference it interferes with crt-d - programmer communication when using non wireless telemetry.Troubleshooting steps were advised.If troubleshooting was unsuccessful the patient would be re-scheduled for follow up evaluation at a different facility.The crt-d, lv lead and encore programmer remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ S CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9644356
• Report Number: 3004209178-2020-02141
• Device Sequence Number: 2500982
• Product Code: NIK
• UDI-Device Identifier: 00643169530195
• UDI-Public: 00643169530195
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 01/28/2018
• Device Model Number: DTBB1D4
• Device Catalogue Number: DTBB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR