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 Dehydration (1807); Fall (1848); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Paresis (1998); Rash (2033); Swelling (2091); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Depression (2361); Fluid Discharge (2686); No Code Available (3191)

Event Date 10/23/2001

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for nausea and vomiting.Non-device related symptoms included back pain secondary to multiple surgeries related to lumbar degenerative disk disease (lddd).Diagnostic procedures were performed including laboratory work and intravenous (iv) fluids.No abnormal results were noted.The event ended on (b)(6) 2001 as the patient recovered with therapeutic action.An unknown amount of time following the discharge, the patient started having more problems with nausea and vomiting.There were ¿a couple¿ episodes where the patient had fallen and complained at times with her heart seeming to pound and having chest discomfort.Approximately 2 months after the discharge, the patient was back in the hospital to try to get the gastroparesis, nausea, dehydration, and vomiting under control.Non-device related symptoms included muscle spasms, back discomfort, and pain secondary to lddd.It was noted that some of the patient¿s syncopal type episodes were related to getting a little hypoglycemic, where hypoglycemia was due to the patient¿s history of insulin dependent diabetes mellitus (iddm).Physical examination found decreased skin turgor and rash on abdomen which "looked like" it was "probably fungal." diagnostic procedures were performed including x-ray of back and laboratory work; medication was administered including iv fluids.The patient reportedly was doing better and was ¿stable¿ so she was sent home.The event ended on (b)(6) 2002 as the patient recovered from the event with therapeutic action.On (b)(6) 2002, the patient was again admitted for nausea, vomiting, and dehydration.Other complaints included hypertension, depression, and swelling in her ankles.Laboratory work was conducted and medicine was administered, including several iv fluids and medication.Physical examination found decreased skin turgor and decreased swelling of ankles using iv medication.The device had "not had much luck on an outpatient basis of keeping her under control." the event reportedly ended in 2002.The patient was admitted to the hospital with recurrence of nausea, vomiting, and dehydration secondary to gastroparesis.Other complaints included hypotension, hypertension, urinating problems, depression, and gastroparesis.Multiple iv fluids and medications were administered and she was subsequently given food, insulin, and pain medication.The patient's activity gradually increased and the iv fluids were tapered down, and the patient was "doing much better." physical examination found that the abdomen was "somewhat tender," usual pain in extremities, swelling of ankles, and skin turgor was decreased "a little bit." after "doing fairly well," the patient had been sent home on medications.The event ended on (b)(6) 2002 as the patient recovered with therapeutic action.On (b)(6) 2002, the patient was admitted to the hospital for nausea, vomiting, and dehydration.Other complaints included gastroparesis, hypertension, a lot of pain when lying in bed for a period of time, a lot of discomfort, and slow moving.Laboratory work was conducted and the patient was given multiple iv fluids and medications.Physical examination found slight nasopharyngeal drainage, tenderness of abdomen, decreased skin turgor, and ankle edema.It was noted that there was no evidence of acute infection problems.The event ended on (b)(6) 2002 as the patient recovered from 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: 4301-35, 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: 4096091
• MDR Text Key: 4702455
• Report Number: 6000032-2014-00206
• 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: 12/21/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2001
• Date Device Manufactured: 10/25/2000
• 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: 00054 YR