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

Model Number	DTBB1QQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 407652 lead, implanted on (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
In response to the advisory noting the potential for internal device arcing during high-voltage charging, the cardiac resynchronization therapy defibrillator (crt-d) was prophylactically replaced.No device malfunction was observed while the device was in use, however, given the potential for loss of device functionality, the crt-d was explanted and replaced to preclude harm to the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.Evaluation summary: the device was returned and analyzed.Device passed initial functional test, however the device failed extended high voltage cycle testing and failed residual gas analysis for internal device minimum nitrogen content.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA QUAD S
• 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: 7416117
• Report Number: 3004209178-2018-07270
• Device Sequence Number: 1097253
• Product Code: NIK
• UDI-Device Identifier: 00643169530218
• UDI-Public: 00643169530218
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/14/2017
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0584-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 102