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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, 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) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that a ¿sensation¿ was felt when the stimulation was on vs.Off.The patient reported that their umbilicus puckered when the stimulation was on.No pain was noted.There were visible muscle contractions around the umbilicus and the sensation was what a baby kicking may feel like.When the patient stood up was when they felt the stimulation the most and the sensation was greater after meals.The patient couldn¿t recall an event that contributed to this sensation.The stimulation was turn down, but the patient still felt the sensation so the stimulator was turned off.An x-ray was taken to check for lead migration and it did not appear the leads had migrated, but two foreign bodies were on the x-ray.It was undetermined what the foreign bodies were.The issue was not resolved at the time of the report and the patient was referred back to the implanting surgeon for evaluation.On 2019-12-04, it was reported that the patient was sent back to the implanting surgeon, but no determination had been made about the foreign bodies on the x-ray.A future procedure hadn¿t been planned at this time.No device issues or further complications were reported or anticipated.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the foreign bodies were deemed irrelevant.The patient¿s stimulation was turned back on nominal settings without incident and the patient seemed to be doing well.No further patient complications were 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: 9415608
• MDR Text Key: 169289968
• Report Number: 3004209178-2019-23136
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Date Device Manufactured: 08/15/2018
• 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 Age: 61 YR
• Patient Weight: 55