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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
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
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 TREATMENT DATA
Date Received: 03/05/2018 Patient Sequence Number: 1
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
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