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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Dysphagia/ Odynophagia (1815); Irritation (1941); Pocket Erosion (2013)

Event Date 02/28/2018

Event Type  Injury  

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.It was reported the patient was short waisted and the ins rolled and came through the skin and the hcp performed a revision.The patient thought the revision was on (b)(6) 2018.The patient stated the hcp tucked it in and placed her on medication.The patient noted it seemed to be fine.The patient stated she was fine at a follow up appointment in (b)(6) 2018.The patient noted that about a week or so after the follow up appointment, the patient couldn¿t swallow and was placed on a piccline for a month.The patient noted they were coughing, she had bad allergies and asthma and was placed on prednisone however, that did not clear up the coughing, the patient stated they worked with an ear nose and throat specialist.It was noted on (b)(6) 2018 had a programming session and frequency was upped.The patient stated that the coughing decreased but was still bad.The patient noted her next appointment was scheduled for (b)(6) 2018 but if the coughing did not improve she would request to be seen sooner.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Device evaluation code (b)(4) corrected to (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the consumer regarding the patient reported the coughing was not related to the device, it was due to an allergy issue.There were no further complications that have been 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: 8028104
• MDR Text Key: 125783587
• Report Number: 3004209178-2018-24440
• 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,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Date Device Manufactured: 01/11/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 89