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 Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Nausea (1970); Paresis (1998); Vomiting (2144); Weakness (2145); Hypovolemia (2243); Test Result (2695); No Code Available (3191)

Event Date 04/04/2002

Event Type  Injury  

Event Description

It was reported that the patient was admitted after a prolonged attempt at treatment of hypovolemia, nausea, and vomiting secondary to diabetic gastroparesis.The patient also had munchausen disease.Prior to admission, the patient received intravenous (iv) therapy at home ¿several times¿ but it failed to control the patient¿s nausea and vomiting, so the patient as admitted on (b)(6) 2002.The patient continued to complain of nausea and vomiting, although they appeared to vomit ¿far less¿ than observed.Medication was administered including iv fluids and the frequency of the episodes declined greatly.The patient¿s antidepressants were stopped for 3 days and concluded to not be contributing to the nausea and vomiting.On (b)(6) 2002, the patient was noted to feel very weak and reported that blood sugar was low.Fingerstick found capillary blood glucose (cb) of 24.Hypoglycemia was a non-device related symptom secondary to diabetes mellitus.This was remedied using medication and boluses of apple juice with sugar mixed in.Insulin pump was discontinued while lantis insulin was administered; the patient's cbgs were in an acceptable range at the time of discharge.It was stated that event proved to be extremely emotionally traumatic and as a result her cbgs ran in the high 500s.During the hospital stay, the patient had ¿quite elevated¿ blood pressure that resulted in ¿satisfactory¿ control after medication was changed.At the time of discharge, the patient was physically and emotionally stable.The event ended on (b)(6) 2002 as the patient recovered from the event 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 neu_unknown_lead, serial # (b)(4), product type lead; product id 4301-35, serial # (b)(4), product type lead.(b)(4).

Manufacturer Narrative

Correction: no additional information received.(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: 4093348
• MDR Text Key: 4713418
• Report Number: 6000032-2014-00203
• 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,Followup
• Report Date: 05/16/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• 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: 09/16/2014
• 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