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

Model Number DTBB1D1

Device Problems Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Discomfort (2330); Impaired Healing (2378)

Event Date 05/19/2016

Event Type  Injury  

Event Description

It was reported that patient had a pocket revision of the cardiac resynchronization therapy defibrillator (crt-d) due to discomfort.The crt-d remains in use.No further patient complications have been reported as a result of this event.

Event Description

It was later reported that the patient's device was poking through the patient's skin.The physician revised the pocket.The patient reported that the site was not healing and the patient had developed cellulitis on the neck and breast.The patient reported hearing alert tones from the device.The patient reported the peripherally inserted central catheter was compromised and caused hemorrhaging.There are plans to extract the device.No further patient complications have been reported as a result of this even it was reported that a pocket infection occurred.The patient was hospitalized and the implantable cardioverter defibrillator (icd) system was explanted.Cultures were taken and the patient was treated with antibiotics.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was returned, analyzed and no anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

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: 5859262
• MDR Text Key: 51695036
• Report Number: 3004209178-2016-15911
• Device Sequence Number: 1
• Product Code: NIK
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/18/2016

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2015
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/09/2016; 11/09/2016
• Supplement Dates FDA Received: 10/06/2016; 02/09/2017; 09/24/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR