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

Model Number 7425G

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Dehydration (1807); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144); Electrolyte Imbalance (2196); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Depression (2361); Test Result (2695); No Code Available (3191)

Event Date 01/17/2002

Event Type  Injury  

Event Description

It was reported that the patient presented with a two-day history of nausea and vomiting, noting that they were unable to keep solids down.Diagnostic procedures were performed including laboratory work, 24 hour urinalysis, and capillary blood glucose (cbg).The patient was also being evaluated for urinary tract infection (uti).After receiving intravenous (iv) hydration and antiemetic therapy, the patient ¿felt improved¿ but not well enough to go home.The patient was admitted for further hydration, nausea control, blood sugar regulation, and workup of her nausea and vomiting.Physical examination found parotid gland hypertrophy, very dry mucous membranes of mouth, diffusely tender abdomen in epigastric region, and a blood pressure increase to 160/98 after four liters of iv fluids.There was ¿moderate¿ improvement in her nausea, but then the nausea returned approximately 2-1/2 hours later.The device reportedly was ¿not working as it had previously.¿ the ¿very brittle¿ and dehydrated patient experienced hypotension followed by hypertension; blood pressure ¿slightly¿ decreased when the patient was first evaluated but increased rapidly when given iv fluids.Medicine was administered for hypertension, depression, abdominal pain, nausea, and vomiting.Non-device related issue that the patient also experienced included anemia secondary to low ferritin and renal insufficiency.Electrolytes were remarkable for glucose, blood urea nitrogen, creatinine, white blood cell count of 9300, and hematocrit.At the time of discharge on (b)(6) 2002, the patient was determined to have a uti with staphylococcus coagulase negative organism after laboratory results came back.The organism was resistant to antibiotic ciprofloxacin which the patient began in the hospital and improved ¿somewhat.¿ the patient ¿recovered¿ and was discharged home on macrodantin as the organism was sensitive to the antibiotic.Three days later, the patient was doing well.However, the patient became ill the following day and went to the emergency room with signs of nausea, vomiting, abdominal pain, and uti.It was noted that the patient also experienced depression.Iv fluids and antiemetics were administered, but the nausea and vomiting could not be stopped so the patient was admitted for further treatment.Additional lab work and blood cultures were performed, revealing leukocytosis as white blood cell count was elevated ¿probably due to a uti.¿ iv clindamycin was administered, and chest x-rays as well as other sites of infections were considered.The event ended on (b)(6) 2002 as the patient recovered from event with therapeutic action.The patient was admitted again for nausea, vomiting, and dehydration approximately 2 weeks later for having ¿increased nausea and vomiting times in two weeks.¿ the patient was vomiting 5-6 times a day, so iv fluids and antiemetics were administered, but without improvement.There was a decreased intake of food and the patient was now getting nutrition fully through jejunostomy feeding tube as she could not keep anything down orally.The patient also complained of umbilically located abdominal pain with no radiation.Diagnostic procedures performed included chest-xray, urinalysis (which ruled out infection), lab work, kidney ureters bladder test (which showed no obstruction), and anterior-posterior abdomen x-ray.There was a small anion gap metabolic acidosis, but this was resolved with hydration.Physical examination discovered mucous membranes slightly dry without lesion and diffusively tender abdomen while observations included sleepy and moderate stress secondary to (abdominal) pain.The patient¿s diet advanced to clears and then a regular diet as she tolerated.The event resolved the following day as the patient recovered from event with therapeutic action.Further follow-up is being conducted to obtain more product problem information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id: neu_unknown_lead, serial# (b)(4), product type: lead.Product id: 4301-35, 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: 4068754
• MDR Text Key: 4852673
• Report Number: 6000032-2014-00187
• 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: 02/13/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/13/2002
• 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; Required Intervention
• Patient Age: 00030 YR