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

Model Number	DTBA1QQ
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: 5076-52 lead implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the patient that during the replacement procedure, the physician threaded the lead into the wrong leg of the vein, and it ended up in the wrong placement.The patient noted that during the replacement procedure, the power went out in the entire city and the generated did not kick in right away.The physician was in the middle of threading the lead into the vein when the power went out.Patient noted that the lead ended up too close to a huge nerve and when the lead was connected to the cardiac resynchronization therapy defibrillator (crt-d), the lead provided therapy.The patient would start jumping around because of the voltages that was felt.Reprograming was done due to the leads being backwards, which was not recognized until afterwards.Patient further reported that during a visit to the clinic, a heart monitor was put on the patient and it showed that during exercising, the patient heart would become slow.The patient reported being so weak that they are unable to get out of bed some days.Reprogramming was done again due to the crt-d getting information backwards.Patient noted that the device would make the heart go lower when exercising because information was sent backwards to the device.Patient noted that the device had to be reprogrammed to work backwards and take in data backwards.Patient noted that the device is working like a ¿charm¿ ever since the reprogramming.The device and leads remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD XT 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: 11753148
• Report Number: 3004209178-2021-06997
• Device Sequence Number: 4168569
• Product Code: NIK
• UDI-Device Identifier: 00643169929326
• UDI-Public: 00643169929326
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 02/28/2019
• Device Model Number: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/30/2021
• 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: 6935M62 LEAD, 459888 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR