Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA STOCKERT 3T
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA STOCKERT 3T Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dyspnea (1816); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067)
Event Date 01/08/2014
Event Type  Injury  
Event Description
On (b)(6) 2014, i had open heart surgery at (b)(6) hospital, (b)(6) which is a (b)(6) facility.Had thoracocentesis about 3 days after surgery.Bilateral pneumonia after discharged, had nebs, o2, etc.I have had trouble with my lungs since surgery.The stockert 3t was used during the surgery, which i didn't get a letter about until (b)(6) 2016 which was too late for a lawsuit to happen.On (b)(6) 2015 i was diagnosed with mycobacterium chimaera from a sputum specimen.I was admitted to icu several times in 2017 with sepsis, fever, had to get home o2, fatigue, only symptom i didn't have was weight loss.I have already been admitted (b)(6) 2018 with sepsis.I carry a cough and most of the time, a green sputum.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STOCKERT 3T
Type of Device
STOCKERT 3T
Manufacturer (Section D)
LIVANOVA
MDR Report Key7316396
MDR Text Key101654791
Report NumberMW5075658
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ALBUTEROL INHALER; AMATRIPTYLINE; ASPIRIN 81MG; EFLEXOR; GABAPENTIN; LIPITOR; METOPROLOL; NITROSTAT; PLAVIX; PROTONIX; RENEXA; REQUIP; SENNA; SPIRONOLACTONE ; STOOL SOFTNER; SYMBICORT INHALER; TRAMADOL; TRAZADONE; TUMS; XANAX; ZANAFLEX
Patient Outcome(s) Hospitalization; Disability;
Patient Age44 YR
Patient Weight86
-
-