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

Model Number 7425G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Calcium Deposits/Calcification (1758); Diarrhea (1811); Inflammation (1932); Nausea (1970); Paresis (1998); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Dizziness (2194); Discomfort (2330); Abdominal Cramps (2543); Test Result (2695); No Code Available (3191)

Event Date 09/21/2001

Event Type  Injury  

Event Description

It was reported that a patient with a history of depression and hypertension was admitted to the hospital for syncope.The patient had been feeling weak for a few days prior to admission with decrease in oral intake and appetite.On evening of admission, the patient had an episode of diarrhea and felt light-headedness while using the toilet resulting in the patient to pass out.There were also symptoms of emesis and nausea, as well as ¿crampy¿ abdominal pain which was relieved with defecation.During admission, the patient was placed on telemetry, given antiemetics, and was hydrated with intravenous fluids after they were found to be orthostatic; the syncopal episode was thought to be due to dehydration and orthostatis.Cardiac enzymes were obtained to rule out cardiac etiology and they were negative.Other diagnostic procedures included electrocardiogram (which was unremarkable), abdomen imaging, and laboratory work.The abdomen view showed calcification within seminal vesicles normally found in a diabetic patient, but was otherwise unremarkable.Laboratory results showed elevated white blood cell count upon admission, but the patient was afebrile.Blood cultures, urine cultures, and a chest x-ray were obtained but no definite source of infection could be identified.The patient was put on levaquin for a possible urinary tract infection (uti).Gastroenteritis was also considered as the cause for leukocytosis.Physical examination found dry mucous membranes and tender abdomen.The following day, the patient began to ¿feel much better¿ with less nausea and vomiting; he was tolerating an oral diet.The device was checked and all parameters were in range.On the day of discharge, the patient denied any nausea, vomiting, and diarrhea.The final diagnosis was syncopal episode and gastroparesis.The event ended (b)(6) 2001 and the patient recovered with therapeutic action.Additional follow-up is being conducted.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id 4351, serial# (b)(4), product type lead; product id 4351, serial# (b)(4), product type lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, 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 Key: 4170319
• MDR Text Key: 4874840
• Report Number: 6000032-2014-00234
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2001
• Date Device Manufactured: 06/07/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization