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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA QUAD S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTBB1Q1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Fluid Discharge (2686)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 5076-52 lead, implanted: (b)(6) 2004; product id: 429878 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was a device pocket hematoma status post multiple revisions.There was slight wound dehiscence with drainage.The patient was referred for a full system extraction due to an infection that developed after the multiple revisions.A wound vacuum assisted closure was placed.The patient declined a replacement system and wore an external defibrillation system.A new cardiac resynchronization therapy defibrillator (crt-d) system was placed two years later.No further patient complications have been reported as a result of this event.
 
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Brand Name
VIVA QUAD S CRT-D
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11322484
MDR Text Key231647675
Report Number3004209178-2021-02515
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00643169530201
UDI-Public00643169530201
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/12/2021
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? No
Device Operator Lay User/Patient
Device Expiration Date04/14/2018
Device Model NumberDTBB1Q1
Device Catalogue NumberDTBB1Q1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2021
Initial Date FDA Received02/12/2021
Date Device Manufactured10/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
693565 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight100
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