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

Model Number 37800

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Weight Changes (2607)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3116, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: implantable neurostimulator.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2008, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 26-mar-2010, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 25-mar-2010, udi#: (b)(4).This event was also reported under manufacturer report # 3004209178-2020-08382.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 (ins) for gastric stimulation.It was reported that the patient started having visible stomach contractions and their symptoms returned towards the end of their first inss life.The device was replaced and they thought this would fix the issues, but it didn't.Their symptoms were worse shortly after implant than they previously were.The patient was experiencing uncomfortable and painful muscle contractions on the left side of their abdomen.They noted they contracted in a rhythmical pattern.The patient saw a correlation with this once they had eaten something and had food in their stomach.The patient took a video of this and showed it to a manufacturing representative (rep).The rep turned the intensity down and stated they believed the issue could be related to electrode erosion since the lead was not replaced during the ins replacement.The patient stated the decreased intensity did not help with the issue.The patient believed these issues were related to the lead not being replaced at their most recent replacement surgery and the issue persisted.The patient further mentioned being on an iv and losing weight and having a lot of boney protrusions.They did not provide any additional information regarding this.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 3116, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: implantable neurostimulator; product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They provided their weight at the time of the event.They stated the electrode erosion was only suggested as a possible cause for the abdominal contractions by a manufacturer representative (rep).They stated it has become clear the contractions only occur following a moderate food/fluid consumption.The frequency of the contractions has greatly decreased by eating or drinking smaller amounts throughout the day.The patient has contacted the rep to readjust settings and will have their surgeon investigate possible lead dysfunction as soon as possible.The issue has not been fully resolved at the time of the report due to health care restrictions and the patient¿s personal health status.No further patient complications were reported as a result of this event.[refer to manufacturer report #3004209178-2020-08382 for details pertaining to the reportable related event.].

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10043255
• MDR Text Key: 190546458
• Report Number: 3004209178-2020-08383
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Report Date: 06/23/2020

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: 03/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/24/2020
• Date Device Manufactured: 10/08/2019
• 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: 48 YR
• Patient Weight: 45