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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event is an approximation.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that ever since the patient started chemo treatment for breast cancer ((b)(6) 2018) and had breast surgery, the patient had been having issues that the patient did not know if they were caused from the device.The patient started to feel things from their stimulator that they had never felt before; they felt the device ¿kick on¿ and they got electrical shocks.The patient had also been experiencing bad muscle spasms but was unsure if that was from the device or side effects of the chemo.In the past few weeks, the patient started experiencing pain where the device was located and noticed that their device moved perpendicular in their stomach and was sticking out and had become more prominent; the patient could physically see their stomach jumping.It was noted that these issues did not occur all the time, but the patient wanted it checked to see if there was an issue with the device or just post-cancer/chemo issues; however, the patient could not get anyone to call them back from their healthcare provider¿s (hcp) office.No further complications were reported/anticipated.

• 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: 9427787
• MDR Text Key: 176114542
• Report Number: 3004209178-2019-23266
• 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
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Date Device Manufactured: 12/10/2015
• 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 Age: 44 YR