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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of gastric stimulation and gastrointestinal/pelvic floor.It was reported that the patient thought the lead had come out because they were feeling shocks.They stated initially it was ¿here and there¿ but now it was every 5 minutes.They stated it felt like a burning sensation.No further patient complications were reported as a result of this 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: 10258896
• MDR Text Key: 198388155
• Report Number: 3004209178-2020-11980
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: 07/10/2020

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: 03/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/10/2020
• Date Device Manufactured: 09/17/2014
• 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 Age: 30 YR