MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Disconnection (1171); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Insufficient Information (3190); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator (ins) for gastric stimulation.It was reported that the patient¿s device was acting funny so they went to the hospital.While there, their healthcare professional (hcp) determined that the patient¿s device had ¿tripped off¿ somehow, but they didn¿t know how.The patient noted they hadn¿t been around any electromagnetic interference (emi) or had any falls.While at the hospital, the patient stated they were attacked on the (b)(6) (unknown month).After they were attacked, they started having issues with the device so they had an x-ray.The x-ray determined that the lead was dislodged from the device.The patient needed surgery to resolve this, but needed to contact a manufacturer representative (rep) prior to having surgery.The patient noted they could not eat or drink at all when the device was off.The next day, it was reported that the patient had a shocking feeling in their abdomen.A belt was used across the patient¿s abdomen, causing pain and shocking.It was also noted that a device interrogation found the lead impedance was out of range around (b)(6) 2020 and (b)(6) 2020.The device was reprogrammed and offered to be turned off by the hcp, but the patient refused to turn the device off because they did not want symptom return.Surgical intervention was planned in the coming weeks.No further complications were reported or anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10018274
• MDR Text Key: 193006854
• Report Number: 3004209178-2020-08006
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Date Device Manufactured: 10/27/2010
• 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