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 Chest Pain (1776); Paresis (1998); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the patient noted the last time therapy was checked was about a week ago by healthcare provider went into the hospital.Their gastroparesis was getting worse and stated the device never really has helped.When asked what did the healthcare provider say about the patient therapy, the caller states that the patient should control blood sugars.The hcp (healthcare provider) has had turn around in the office and that there was discussion about a doctor who has more experience.The patient was currently going in everyday or every other day to the hospital for his gastroparesis symptoms.Additional information reports it was unknown if there was a fifty percent or greater symptom reduction.The cause of the event was not determined.It was unknown if it was device related and no reprogramming was needed.The patient had not been compliant with glucose management despite many attempts to encourage it.The device adjusted voltage bumped up to 6.1 from 4.6.The patient was in er (emergency room) with chest pains the date the device was adjusted.Impedance was 566 and voltage 4.6.The patient not recovered, symptoms/issues ongoing.The patient does not follow treatment plan.The patient will not manage glucose.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 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: 4408990
• MDR Text Key: 14880937
• Report Number: 3004209178-2015-00521
• 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: Other
• Type of Report: Initial
• Report Date: 12/15/2014

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: 09/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/12/2015
• Date Device Manufactured: 03/19/2014
• 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
• Patient Age: 00039 YR