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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, lot#: unknown, implanted:( b)(6) 2019 , product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported high impedance for electrode 3 (2500 ohms).There was no therapy effect.No factors that may have led or contributedto the issue.Actions taken included a revision surgery and the lead was disconnected and re-enetered again.Loosening the setscrew for the top lead (electrode 3) was described as with low resistance compared to normal perception when loosening the set screw.Impedance check was performed again and all impedances were in normal range (300-500 ohms).The issue was resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10562768
• MDR Text Key: 208000715
• Report Number: 3004209178-2020-16361
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/21/2020
• Date Device Manufactured: 12/10/2018
• 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 Outcome(s): Required Intervention