MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Low Battery (2584)

Patient Problems Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 08/02/2013

Event Type  Injury  

Event Description

The consumer reported that the patient had trouble with the device since day 1, ever since they put it in.It kept shutting off and since implant on (b)(6) 2013 , the device caused the patient to be sick.The patient had a loss of therapy and therapy stopped helping in (b)(6) 2015.The patient's device seemed to be turned off and the patient had a lot of trouble with it.The device kept cutting off and was not on.The device didn't help and was not working.The patient just got out of the hospital and was in the hospital because of the stimulator.A health care provider (hcp) came to the hospital and checked the battery and it was dead.Since then, the patient was not able to get a hold of their hcp.The patient had been seen by the nurse.The indication for use for this patient was gastric stimulation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5772030
• MDR Text Key: 48844535
• Report Number: 3004209178-2016-13543
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: 06/13/2016
• Supplement Dates FDA Received: 09/24/2017
• Date Device Manufactured: 05/22/2013
• 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: 56 YR