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

Model Number 37800

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problems Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/09/2018

Event Type  malfunction  

Manufacturer Narrative

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 and gastrointestinal/pelvic floor issues.It was reported that the patient went in for their 2-week post-op exam and the healthcare provider (hcp) found the ins had been turned off.It was noted that the hcp did not report any sort of reset or por and after reviewing the patient¿s activities, they suspected that it was from security gates.The hcp turned the therapy back on at the appointment last tuesday.It was noted that the patient¿s symptoms were getting better after implant, but they noticed they were not feeling great and had bad nausea for a couple of nights.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient complained of nausea and vomiting daily since last week, felt like before the pacer was placed or thought the pacer may be turned off that happened last month; however, it was also reported that the pacemaker was not turned off.The voltage was increased from 4.0 volts to 8.0 volts, the impedance was 476, and cycle on 1.0, cycle off 5.0.A follow-up was scheduled for 6 weeks.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: 8173507
• MDR Text Key: 130706057
• Report Number: 3004209178-2018-27875
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2019
• Date Device Manufactured: 04/16/2018
• 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: 77