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); Edema (1820); Nausea (1970); Paresis (1998); Vomiting (2144); Discomfort (2330); Hypoesthesia, Foot/Leg (2354); Depression (2361); Test Result (2695); No Code Available (3191)

Event Date 09/04/2001

Event Type  Injury  

Event Description

It was reported that after the patient had the implant, the patient continued to have nausea and vomiting due to gastroparesis.Medicine was administered and it was stated that the device was expected to be fully functional in two to three weeks after starting.The patient also started receiving jejunal feedings with magnacal renal supplements since her albumin was "very low." the patient was "extremely depressed" during her hospital stay.Physical examination found dry mucous membranes, diffusely tender abdomen, decreased bowel sounds, bilateral lower extremity edema up to mid-calf, and decreased sensation to the knee.Two of the diagnoses were gastroparesis and physical deconditioning due to prolonged bed rest during hospitalization.Other symptoms that the patient experienced were non-device related including peripheral vascular disease secondary to diabetes mellitus, necrosis of right second toe and left big toe, gangrene, and candida peritonitis and infectious disease all of which occurred prior to implant; the infection was resolved with no growth in bacterial cultures.During the patient's 50 day hospitalization, the operations and procedures for all conditions , device related or not, included the following: bone scan, arteriogram, jejunal feeding tube placement, peritoneal dialysis, gastric pacemaker placement, hemodialysis, infectious disease consultation, general surgery consultation, vascular surgery consultation, renal consultation, and psychiatrist consultation.Two weeks after implant, the patient was transferred to a new hospital.No final outcome was given.Additional follow-up is being conducted to obtain this information.Any additional information received will be captured in a supplemental report.

Manufacturer Narrative

Concomitant medical products: product id: 4301-35, serial# (b)(4), product type: lead.Product id: 4301-35, serial# (b)(4), product type: lead.(b)(4).

Event Description

Additionally, the patient died secondary to voluntarily stopping her dialysis.The physician stated that the death was not related to the device.

Manufacturer Narrative

Correction - previously, death determined to be a related event that was determined to not be a complaint per regulations.After review, sending a supplemental due to unrelated death just to close the loop.The death was said to be not related to enterra, therefore we do not need to change the coding of the file to capture that.Not late as not critical information relating to the device (since unrelated), and has no effect on coding or final outcome related to the device.

• 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: 4096255
• MDR Text Key: 20069832
• Report Number: 6000032-2014-00207
• 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: 02/20/2002

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: 02/10/2015
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• 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: 00043 YR