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 Abdominal Pain (1685); Chest Pain (1776); Dehydration (1807); Diarrhea (1811); Dyspnea (1816); Sepsis (2067); Dysphasia (2195); Urinary Frequency (2275); Malaise (2359); Lethargy (2560); Test Result (2695); No Code Available (3191)

Event Date 12/12/2001

Event Type  Injury  

Event Description

It was reported that the patient became ill with ¿profound¿ diarrhea and dehydration, noting that the diarrhea was ¿not new.¿ the patient improved after he was given intravenous (iv) fluids, but then worsened again that night, becoming more lethargic, having more excessive urination and diarrhea, and experiencing chest pain that was ¿mildly pleuritic¿ in nature.The patient was admitted to the hospital.Intermittent abdominal distress, slurred speech, and dyspnea were also noted.Non-device related symptoms included an upper respiratory infection or sinusitis in which cultures were taken, hyperglycemia due to underlying diabetes, chronic leg pain, decreased vision and cataracts, skin lesions and infections including diagnosed scabies, and puncture of lungs as a result of central line placement.Laboratory results showed ¿dramatic abnormalities¿ in his chemistries with serum glucose of approximately 1100, serum sodium of 114, ph of 7.349, dry mucous membranes, and white blood cell count at 16,000.Sepsis and hyponatremia were suspected, but physical exam did not show any obvious source of sepsis.The patient received medication included zithromax, intravenous (iv) fluids, iv insulin, and empirirc antibiotic coverage.Surgery was not performed.It was noted that the event ended on (b)(6) 2001 where the patient recovered from event with therapeutic action.Not clear of medical status prior to event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id neu_unknown_lead, serial# (b)(4), implanted: 2001 (b)(6); product type lead product id neu_unknown_lead, serial# (b)(4), implanted: 2001 (b)(6); 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: 4064430
• MDR Text Key: 4736610
• Report Number: 6000032-2014-00184
• 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: 01/23/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2002
• Date Device Manufactured: 05/23/2001
• 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: 00022 YR