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

Model Number 3116

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Chest Pain (1776); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359); Impaired Healing (2378)

Event Date 07/01/2015

Event Type  Injury  

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

The consumer reported that therapy was not an easy thing to get used to.It took 6 months for the patient to feel good and it was rough.The patient found out when they woke up in the recovery room that they had to put air inside of them, which they didn¿t know, and they should have explanted the process and procedures to them so they would know the symptoms.The patient thought they were having a heart attack, but they were not and it took 3 to 4 months to heal and it was treacherous.The patient had pain in the left shoulder and chest.The patient mentioned having multiple sclerosis.The patient had a malfunction with their implant.The patient was not sure what happened and neither were the health care providers (hcps).The patient had a very bad fall down the stairs in (b)(6) 2015 and they believed they jarred the implantable neurostimulator (ins) and fractured discs in the lumbar spine.The patient could not make it to their hcp¿s office because of the pain after the fall and the setting was 5.33v.The patient went to see their hcp in (b)(6) 2015 and they said the ins was turned off.The patient said the implant was on at 5.33v and told the hcp they fell.The hcp turned therapy back on at 6v and the patient felt very good, but noticed 4 days later the symptoms came back and they called their hcp¿s office.The hcp tested the implant and it was turned off and they decided the ins needed to be replaced.The ins was replaced on (b)(6) 2016.The indication for use for this patient was gastrointestinal/pelvic floor.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5806704
• MDR Text Key: 49943484
• Report Number: 3004209178-2016-14523
• 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: 07/19/2016

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: 05/28/2016
• 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: 06/28/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: 06/28/2016
• Supplement Dates FDA Received: 09/24/2017
• Date Device Manufactured: 12/13/2014
• 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): Required Intervention
• Patient Age: 60 YR