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

Model Number 37800

Device Problems Intermittent Continuity (1121); Battery Problem (2885)

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144); Electrolyte Imbalance (2196); Therapeutic Response, Decreased (2271); Discomfort (2330); Weight Changes (2607)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient saw their healthcare professional (hcp) probably two and a half weeks prior to the report and they found that the implanted neurostimulator (ins) battery was low.The patient stated they had really high settings and felt ¿when it goes off every five seconds or so [they] had a return of symptoms¿.This return of symptoms started two months or so prior to the report.It stopped going off regularly, noting that it was taking 15 minutes or more and was very sporadic.They started to get a return of symptoms like vomiting and an inability to eat.The patient was on a liquid diet at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that the device was removed and replaced on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that they had a loss of therapy.The previous issues were addressed by a hcp and they said "it had 10% life remaining and, instead of scheduling for the replacement, they turned the battery up as high as it would go to get better coverage.This was done on (b)(6) 2018, and the patient started feeling a hard stimulation, like a heart punch that vibrated their sternum," and noted that this was uncomfortable stimulation.The patient then stated that it died and went completely dead on the following saturday.The patient was in the hospital at the time of the report and stated it was because of the system; they hadn't eaten for six days and they couldn't keep anything down.Their electrolytes were "screwed" and they had lost ten pounds.They noted the hcp wanted to wait until (b)(6) 2018-11-29 to do the replacement.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8002067
• MDR Text Key: 125183985
• Report Number: 3004209178-2018-23832
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

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: 01/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/07/2018; 11/20/2018
• Supplement Dates FDA Received: 11/08/2018; 11/26/2018
• Date Device Manufactured: 08/08/2015
• 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: 46 YR