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

Model Number 3116

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Weakness (2145); Complaint, Ill-Defined (2331)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported that their healthcare provider (hcp) told them that the implantable neurostimulator (ins) was not working and they were getting ready to do surgery but the hcp was arrested.The patient was looking for a new hcp as they needed their ins to be replaced.An hcp list was sent to the patient.No further complications are anticipated.

Event Description

Additional information from the patient reported they had appointment with another hcp on (b)(6) 2017.On (b)(6) 2016 they started feeling the effects of the device not operating correctly, during normal use.The device was implanted approximately five years prior and they the conclusion was battery failure.Symptoms included, weak, nausea, vomiting, felt full and wasn't digesting food.The patient reiterated that their surgery was cancelled due to the physician being arrested.Additional information from the hcp confirmed that the battery was nearing end of life and the patient was scheduled for a replacement.No further communications were reported/anticipated.

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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6418204
• MDR Text Key: 70417382
• Report Number: 3004209178-2017-05954
• 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,Followup,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Date Device Manufactured: 12/05/2011
• 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 Age: 56 YR