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

Model Number 37800

Device Problem Unintended Collision (1429)

Patient Problems Nausea (1970); Twitching (2172); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 10/05/2019

Event Type  malfunction  

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 their impedances were at 527 ohms.The patient was fairly certain they got a virus, which may have been what caused the nausea/stomach issues.On (b)(6) 2019, the patient reported it was determined that the fall did not affect the stimulator.Their nausea persisted, but the tenderness and twitching resolved.

Manufacturer Narrative

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 gastrointestinal/pelvic floor.It was reported that the patient¿s dog pulled them down and dragged them on their stomach about 5 feet on (b)(6) 2019.By (b)(6) 2019 they had terrible nausea and were sick to the stomach.The patient stated it could have been due to something else.The nausea was severe for 2 days and did not go away.The abdomen felt kind of tender around the ins.The patient stated they can feel that it is there and they had not felt it before.They felt occasional twitching.They stated they are pretty thin and the device is prominent on them but it did not look obviously out of place.The patient mentioned they saw the doctor a month ago and everything was fine.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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9286915
• MDR Text Key: 170803030
• Report Number: 3004209178-2019-21189
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Date Device Manufactured: 08/24/2018
• 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: 39 YR
• Patient Weight: 52