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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number C6TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Hematoma (1884); No Code Available (3191)
Event Date 12/21/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant products: 439688, lead, implanted: (b)(6) 2016.
 
Event Description
It was reported that the patient presented to the emergency room with a complaint of bleeding from the pacemaker incision site for two days. The patient reported having blood around the pacemaker site and left side of the neck in the mornings. The patient also reported that the insertion site was still sore. Assessment of the chest wall reveled oozing from the incision site opening. The patient had minimal tenderness and no soft tissue swelling. The patient received four stitches to the incision site and was discharged home the same day. Five days later, the patient was seen in the clinic for a wound check. A hematoma was noted over the pacemaker and the area was bruised and firm to palpate. No active bleeding was noted. The cardiac resynchronization therapy pacemaker (crt-p) remains in use. The patient is a participant in the (b)(6). No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameVIVA XT CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6317733
MDR Text Key67084367
Report Number9614453-2017-00280
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2017
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2017 Patient Sequence Number: 1
Treatment
407652 LEAD, 407658 LEAD
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