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

Model Number 37800

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Environmental Compatibility Problem (2929); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Type  malfunction  

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 the reason for the call was to report the patient was getting shocked all the time, and if they touched someone, sometimes the patient shocked them.The caller stated they thought this may be due to the patient's ins being "on the fritz" or "going bad." they inquired if this shocking could hurt the patient or someone else.The role of the manufacturer help line was reviewed, and the caller was redirected to the patient's healthcare provider (hcp) to discuss this issue.Normal device function was reviewed.The caller stated when the patient went to touch someone, they could see a shock come from the patient.The caller confirmed the patient did not use metal and did not use a chalkboard at work (the patient's profession was a teacher).They confirmed the hcp had been informed of this issue.The caller denied the patient having any recent trauma or falls.They could not recall the location of the shocking sensation, and stated they thought it was "kind of in [their] stomach," but stated it had come off the patient's hand.The caller provided the event date as "probably about two months ago, or six weeks ago." they stated the patient's previous managing doctor had retired, and that the patient would be seeing a managing hcp in april.The patient was redirected to their healthcare provider to further address the issue.

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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13701199
• MDR Text Key: 287331976
• Report Number: 3004209178-2022-03013
• 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
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• Date Device Manufactured: 06/16/2017
• 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 Sex: Female