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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Vomiting (2144); Sleep Dysfunction (2517); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A manufacturing representative (rep) reported on behalf of healthcare provider (hcp) that a patient was having pocket pain and their battery was flipping.The hcp was going to revise the patient's pocket on (b)(6) 2018 where the battery was located.A note from the hcp office dated (b)(6) 2017 stated the patient presented with persistent nausea and vomiting, though they say they had improved with their gastric stimulator.There were no fevers or infections, no dysuria, polyuria, and urinary urgency.They were having persistent and worsening pain at their pacer site related to the pacer flipping around in its pocket.The pain would wake them up in the middle of the night and they had to reposition the stimulator to help the pain.They were requesting pain medication.They felt shocking pain at their pacer site as well.It would come on without warning and could be quite severe.It was noted they still had constipation.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 7178253
• MDR Text Key: 96837587
• Report Number: 3004209178-2018-00522
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: 07/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 01/10/2018
• Date Device Manufactured: 02/09/2017
• 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 Outcome(s): Required Intervention