• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR

  • 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
 

MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 7425G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Diarrhea (1811); Dyspnea (1816); Encephalopathy (1833); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Paresis (1998); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012); Pulmonary Edema (2020); Renal Failure (2041); Respiratory Distress (2045); Staphylococcus Aureus (2058); Tachycardia (2095); Vomiting (2144); Electrolyte Imbalance (2196); Ulcer (2274); Discomfort (2330); Complaint, Ill-Defined (2331); Depression (2361); Fungal Infection (2419); Irritability (2421); Obstruction/Occlusion (2422); Low Oxygen Saturation (2477); Respiratory Failure (2484); Increased Respiratory Rate (2486); Cognitive Changes (2551); Test Result (2695); No Code Available (3191)
Event Type  Death  
Event Description
It was reported that the patient was hospitalized after a two week history of nausea and vomiting.The patient ¿usually¿ experienced nausea in the morning upon getting up and when medication was increased, his nausea and vomiting worsened over the last 4-5 days and blood sugars increased.It was noted that the symptoms were ¿likely¿ secondary to gastroparesis status post device placement.During admission, the patient also complained of abdominal pain with vomiting, hypertension, asymptomatic hyponatremia (likely related to nausea and vomiting), ¿some¿ loose stools, and ¿above in hpi (history of present illness).¿ diagnostic procedures included urinalysis, blood cultures, laboratory work, two views of chest, 2 views of abdomen, and ultrasound of abdomen.Physical examination found tachycardic heart and mild tenderness to palpation in mid-epigastric area, while chest x-ray and ultrasound were unremarkable.Urinanalysis had few bacteria, but showed no infection.There was no evidence of pneumonia during chest view or obstruction during abdomen view, but the procedures discovered atherosclerotic vascular calcification, renal calculus, and renal sinus lipomatosis.Medications were administered including intravenous (iv) fluids.Nausea and vomiting resolved; there were no episodes of nausea and vomiting during hospital stay.The patient recovered on (b)(6) 2002 and was discharged the following day.Less than two weeks later, the patient was hospitalized again for nausea and vomiting.Nausea and vomiting improved with prevacid and scopolamine patch; however, the patient subsequently developed pneumonia and was intubated due to shortness of breath and increasing hypoxia.The patient was transferred to the intensive care unit (icu) and sedated when he was intubated, but his mental status continued to deteriorate even without sedation.The patient¿s condition continued to deteriorate as he developed renal failure and was requiring hemodialysis.Diagnostic procedures included chest x-rays, abdominal x-ray, perfusion lung scan, ct scan, and electroencephalography (eeg).An abdominal view showed small left-sided pleural effusion, generalized cardiomegaly, calcifications within pelvis which appeared to be within the seminal vesicles, and mild dilation of loops of bowel throughout the abdomen consistent with adynamic ileus.The patient was diagnosed with bilateral upper lobe alveolar type pneumonia with ¿patchy¿ bibasilar infiltrates as well as developed dropping o2 saturations on (b)(6) 2002.The following day, a chest x-ray showed development of pronounced right upper lobe infiltrate suggesting interstitial or alveolar pneumonia, or ¿less likely hemorrhage,¿ so a bronchoscopy was performed.Other considerations included histoplasma pneumonia, aspiration pneumonia due to the patient¿s history of vomiting, and atypical pathogens of his mycoplasma and legionella.Zosyn and vancomycin were administered for broad antibacterial coverage and potential (b)(6) coverage.The following diagnostic tests were being considered, but were not confirmed as to have been performed: urine specimen for legionella and histoplasma antigens, fungal blood culture, nasal pharyngeal swab or bronchoalveolar lavage (bal) fluid for rapid respiratory syncytial virus (rsv) and influenza antigen, compliment fixation titers for mycoplasma, (b)(6) for legionella, and a bronchoscopy study for silver stain, gram stain, acid-fast bacillus (afb) smear, and cultures.Later, it was determined that the patient also had ¿mild¿ pulmonary vascular congestions, infiltrate throughout the right lung as well as bibasilar atelectasis (¿representing pneumonia versus edema¿), progression of bilateral airspace disease, and right upper lobe pneumonia with minimal left upper lobe pneumonitis; the question of infection was raised.Images performed over the lungs showed no evidence to suggest presence of pulmonary embolism.Other assessments included hypertension, depression, and gastroesophageal ulcers.On (b)(6) 2002, a chest view and bronchial wash were performed, respectively.The former showed interval improvement in pulmonary infiltrates while the latter showed acute inflammation.A special stain was negative for pneumocystis cranii and fungal organisms.A tracheostomy was performed on (b)(6) 2002 due to long term respiratory failure and prolonged intubation.Several unsuccessful attempts were made to wean the patient off the ventilator, but he would develop episodes of tachypnea and agitation.A chest view showed improvement in bibasilar atelectasis or pneumonitis; the patient still showed signs of mild to moderate pulmonary venous congestion.On (b)(6) 2002, a chest view showed that the pleural effusion resolved and there was no evidence of pneumonia; the patient still had mild bibasilar atelectasis or pneumonitis.A ct scan from (b)(6) 2002 showed generalized atrophy of the brain and an eeg showed diffuse slowing that indicated moderate encephalopathy; other findings included pan sinusitis, fluid within the frontal sinuses, and opacification of ethmoid air cells and sphenoid sinus.The patient had respiratory distress a week later, as well as dilated loops of small bowel consistent with ileus as shown from kidneys ureters bladder (kub) exam.However, a view of the abdomen four days la ter concluded no evidence of bowel obstruction.On (b)(6) 2002, a chest view showed signs of pleural effusions, persistent bibasilar subsegmental atelectasis or pneumonitis, and pulmonary venous congestion without change.One organism that was isolated was respiratory syncytial virus and chest x-ray infiltrates could not be resolved.On that day, the patient was taken off life support and had passed away.Additional follow-up is being conducted.If any additional information is received, a supplemental report will be sent.
 
Manufacturer Narrative
Concomitant products: product id 4301, serial # (b)(4), product type lead; product id 4301, serial # (b)(4), product type lead.
 
Manufacturer Narrative
Concomitant medical products: product id: 4351, lot# pbp004393k, serial# unknown, product type: lead.Product id: 4351, lot# pbp004305k, serial# unknown, product type: lead.(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENTERRA
Type of Device
INTESTINAL STIMULATOR
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
km0.4
humacao PR 00792
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key4174451
MDR Text Key5102733
Report Number6000032-2014-00235
Device Sequence Number1
Product Code LNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/12/2002
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 Health Professional
Device Expiration Date11/28/2002
Device Model Number7425G
Device Catalogue Number7425G
Device Lot NumberNAT138380H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2012
Initial Date FDA Received10/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received10/16/2014
10/16/2014
Date Device Manufactured06/07/2001
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
-
-