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

Model Number 37800

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Vibration (1674); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 03/22/2018

Event Type  malfunction  

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 gastrointestinal/pelvic floor issues.It was reported that the patient was in the er because they were having a severe migraine where they lost the ability to speak and they were rushed to a ct scan because the er thought they were having a stroke.It was noted that the patient got stroke-like migraines that could last hours to days to weeks and they become expressive aphasic and that these were unrelated to the ins and had been going on since 1994.While the patient was in the ct for a head scan, their ins shocked them 10 times, it was vibrating up, down, in and out, and it hurt really bad in the pocket site.It was noted with the patient¿s ekg, the ins was pacing.The patient could not tell the er to turn the ins off because they had to rush the patient in to see if the patient was having a stroke or not because of the tpa; the er did not turn it off or call anyone.The patient was redirected to follow up with their healthcare provider (hcp) to discuss their symptoms and it was noted the patient had an appointment on (b)(6) 2018, but they would try to contact the hcp¿s pa on monday.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 (con).It was reported that the patient saw their doctor on (b)(4)2018.They had three options: remove the device, turn the device off, or turn the device down.The doctor had never heard of this happening.On (b)(6)2018, another doctor stated they had heard of shocking, but not like this.They readjusted it and the patient was going to return on (b)(6)2018 for another readjustment.The patient stated that the ins had never worked to its full potential.It was also noted they had cardiac issues and wore a patch to record their cardiac.

• 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: 7370643
• MDR Text Key: 103516079
• Report Number: 3004209178-2018-05733
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2018
• Date Device Manufactured: 07/13/2017
• 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 Age: 51 YR
• Patient Weight: 61