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

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Insufficient Information (4580)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that since patient received implant has been hospitalized 4 times for gastroparesis symptoms.Caller said that the first time patient was hospitalized after the implant was two weeks after the implant.Caller said that patient was just admitted again yesterday as patient started vomiting again.Caller said that patient just called her and said that one of the nurses told the patient that implant is malfunctioning.Caller said that it is unknown how they came to that conclusion, caller does not know if device was actually interrogated using clinician programmer.Caller to contact patient and ask the patient if someone with the clinician programmer interrogated the implant and if not, to have patient ask how it was determined that implant is malfunctioning.The patient was redirected to their healthcare provider to further address the issue.After speaking with the patient, caller to contact managing hcp office to report current patient status and ask for additional direction.The patient's relevant medical history included caller said that prior to implant patient received botox treatment for two years.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12608984
• MDR Text Key: 276883732
• Report Number: 3004209178-2021-15169
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Date Device Manufactured: 05/12/2021
• 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): Hospitalization
• Patient Age: 25 YR