MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Complaint, Ill-Defined (2331); Injury (2348); Malaise (2359); Post Operative Wound Infection (2446); Test Result (2695)

Event Type  Injury  

Event Description

The patient reported an event (b)(6) 2014.It was noted that the enterra device was replaced in (b)(6) last year and it got infected.The patient was working with doctor a.Implantable neurostimulator (ins) was not removed.The patient stated she was so sick she almost died.The patient was in 3 different hospitals in a month.The patient stated implanting doctor ( name unknown) did not want to take out ins but dr (b)(6).Thought it should have been removed.The patient noted she went into kidney failure.Additional information provided by the healthcare provider noted that the patient was hospitalized at the (b)(6) and they didn't have those records.This healthcare provider did include a hospital discharge summary with admission date of (b)(6) 2014 and discharge date of (b)(6) 2014.Principal final diagnosis was noted as acute kidney injury.Brief hospital course was noted as: the patient was admitted to the hospital with concerns for wound infection; however, she was found on admission to have acute kidney injury.The patient was made n.P.O.(nothing by mouth).A ct scan was performed, which showed no evidence of tissue infection or wound infection.A foley catheter was placed, and the patient was given iv fluid secondary to her creatinine being elevated to 7.The renal service was consulted, and her elevated creatinine and kidney injury were likely secondary to antibiotics she had received as in inpatient at the (b)(6) just prior to her hospital admission there.The patient was monitored for several days.Her urine output always remained more than adequate.Her creatinine started to decline on hospital day 4, and upon the day of discharge her creatinine was 4.4 and trending down.The patient was given a regular diet, which she tolerated mostly.She still had decreased appetite following her gastric stimulator surgery, which was prior to this admission, at the beginning of (b)(6).The patient was ambulating without assistance.Her foley catheter was removed, and she was urinating without assistance.She was having positive bowel function and had had several bowel movements during her hospital admission.The patient's pain was controlled with norco, and her nausea was controlled with phenergan, both of which she was discharged home on.Disposition was to home and condition was noted as stable.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4) implanted: (b)(4) 2014, product type: lead.Product id: 4351-35, serial# (b)(4) implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4818964
• MDR Text Key: 21562000
• Report Number: 3004209178-2015-10287
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2015

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: 07/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/04/2015
• Date Device Manufactured: 02/06/2014
• 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; Life Threatening; Required Intervention
• Patient Age: 00052 YR