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

Model Number 7425G

Device Problem Compatibility Problem (2960)

Patient Problems Syncope (1610); Dyspnea (1816); Fall (1848); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Muscle Weakness (1967); Dizziness (2194); Neurogenic Shock (2265); Depression (2361); Abdominal Cramps (2543); Ambulation Difficulties (2544); Hematuria (2558); Lethargy (2560); Decreased Sensitivity (2683); Test Result (2695); No Code Available (3191)

Event Date 01/04/2002

Event Type  Injury  

Event Description

It was reported that the patient was experiencing lethargy, depression, hypotension with blood pressure of 70/30, hematuria, and dizziness on (b)(6) 2002.The patient had a ¿problem with balance¿ noting 2 episodes in the past in which her legs suddenly gave way beneath her, clarifying that one event occurred in (b)(6) or (b)(6) 2001 and the second one occurred ¿several days¿ prior to the consultation.During the first occurrence, the patient rested for 30 minutes but her legs were weak.She experienced ¿spontaneous recovery of that weakness over time¿ until her legs gave out recently.It was noted that the patient could not have an mra scan due to the device to test for vertebrobasilar insufficiency.Physical examination revealed dry mucous membranes and stocking glove sensory loss, noting gastroparesis can easily contribute to significant suppression in sensorium and give the patient both the flat effect and monotonal speech that was seen.Non-device related symptoms and conditions were noted during the examination including ¿poorly reactive pupils¿ and ¿post-laser scars of the retina bilaterally as well as areas of retinal infarction;¿ the patient reported ¿graying out of the periphery of her vision.¿ the healthcare provider (hcp) stated that the bouts of hypotension were ¿possibly related to her neuropathy¿ and thought that ¿some¿ of her symptoms as well as her hypotension ¿could be related to psychotropic medications and their centrally acting effects possibly contributing to a neurogenic shock.The patient was given intravenous (iv) fluids and had multiple medications reduced.It was noted that the patient was not hospitalized but went to the emergency room for consultations and was released, however it was also later stated that the patient was hospitalized for hypotension.The patient recovered from event with therapeutic action on (b)(6) 2002.Three days later, it was reported that the patient had been symptom free for a couple days but then was admitted to the hospital for lightheadedness and hypotension.The patient had been ¿increasingly dizzy and lightheaded¿ throughout the day and ¿felt as though she would pass out when she stood up.¿ it was clarified that the patient did not pass out.Dehydration, very poor appetite, weakness, shortness of breath, and ¿crampy¿ abdominal pain were other symptoms the patient experienced.The orthostatic and near syncopal patient was given saline, but blood pressure minimally improved from 66/41 to 73/41.Non-device symptoms included anemia, hyperglycemia with blood sugar of 403 due to diabetes, worsening renal insufficiency, and chronically low hematocrit due to long history of renal failure.Intravenous fluids were administered and medicine doses were changed.Diagnostic procedures included laboratory work, chest x-ray, blood cultures, and urinalysis.The patient as being evaluated for occult infection as white blood cell count was ¿mildly elevated at 11.9.¿ physical examination was unremarkable, noting that the ¿somewhat somnolent¿ patient was clearly hypotensive, but etiology was not clear.Potential etiologies for hypotension and near-syncope included dehydration, diabetic autonomic dysfunction, recent addition of univasc, volume depletion, autonomic insufficiency and consequently neurogenic shock, adrenal insufficiency, and hypovolemic shock.On the third hospital day, the patient became hypertensive with systolic blood pressure on an excess of 150 and even as high as 190-200 systolic.The patient was started on short-acting diltiazem then transitioned to cardizem cd and univasc.The event ended (b)(6) 2002 as the patient recovered with therapeutic action.It was unclear if the patient was hospitalized on (b)(6) 2002 as there were conflicting statements.Follow-up is being conducted for clarification.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2001, product type: lead.Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2001, 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: 4068370
• MDR Text Key: 4736658
• Report Number: 6000032-2014-00185
• 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

• 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
• Initial Date Manufacturer Received: 02/13/2002
• Initial Date FDA Received: 09/08/2014
• 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