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

Model Number DTBB1D1

Device Problems Defibrillation/Stimulation Problem (1573); Invalid Sensing (2293)

Patient Problems Syncope (1610); Death (1802); Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 09/24/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical product: 6945-65 lead implanted: (b)(6) 1998.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient experienced a syncopal episode, was hypotensive and had a hemoglobin level of 5.5 due to a large right chest and right flank hematoma.The patient was treated and was transferred to another facility at which time anti-coagulation (ac) was stopped.The patient received four additional transfusions to maintain the hemoglobin and a compression wrap was applied.Ac treatment was re-started ¿in view of mechanical mitral valve regurgitation;¿ however, the hemoglobin was found to trend downward, and the ac treatment was stopped.The bleeding was determined to be slow and the source was not identified due to the increased risk of worsening renal failure, which could result from a procedure.Following, there was frank rectal blood, the patient developed an episode of sustained ventricular tachycardia (vt) and received a shock from the device.The patient then developed multiple episodes of vt and shocks were delivered nine times.At the time of the last vt episode, the patient was in agonal breathing, the ¿implantable cardioverter defibrillator did not capture and did not fire.¿ the patient had a status of do not resuscitate/do not intubate, went into asystole and was pronounced deceased.The patient was a participant in the (b)(6) clinical study.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was later reported the large right chest and right flank hematoma was not at the pacer site.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA S
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7071279
• MDR Text Key: 93350804
• Report Number: 3004209178-2017-24617
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007185
• UDI-Public: 00643169007185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2017
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/29/2017; 12/11/2017
• Supplement Dates FDA Received: 12/06/2017; 12/22/2017
• Date Device Manufactured: 12/11/2015
• 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: 419488 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 84