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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA STOCKERT 3T
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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.
 
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Brand NameSTOCKERT 3T
Type of DeviceSTOCKERT 3T
Manufacturer (Section D)
LIVANOVA
MDR Report Key7316396
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Age44 YR
Patient Weight86
Patient Treatment(s)
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;
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