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

Model Number 37800

Device Problems Electro-Static Discharge (2149); Electromagnetic Compatibility Problem (2927)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported that they were working with an oxygen refill compressor on (b)(6) 2018 and felt "a little discomfort, like a jolt".They noted that it was nothing alarming and they were not horrible pain.The patient also reported that they felt ¿real discomfort¿ during a thunder storm last summer where they felt the jolt/discomfort sensation.The patent had their device checked when they had the issues.The patient noted that the jolting/discomfort sensation had occurred many times in the past.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 consumer.It was reported that the cause of the patient¿s jolt/discomfort was due to an oxygen refill compressor that was new at a family members¿ home in (b)(6) 2018, and lightning/thunderstorms in the spring/summer of 2017.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: 7182916
• MDR Text Key: 97004624
• Report Number: 3004209178-2018-00644
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Date Device Manufactured: 10/27/2016
• 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: 54 YR
• Patient Weight: 52