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

Model Number 37800

Device Problem High impedance (1291)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: 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.

Event Description

A healthcare provider (hcp) reported that a patient was not getting good therapy.Impedance tests were done and the results indicated "high z on pairs with #2".The results of 2,3 were greater than 4000 ohms.C2 was =>20,000 ohms and c2=354 ohms, 23=>20,000ohms.It was noted that the out of range electrodes were being used in programming and causing therapy problems.It was reviewed with the hcp that they may consider replacing the lead involving #2 as it appeared to have an open circuit.The hcp stated they were doing a surgical procedure that day to address the high impedance and change out the lead.There was no lead migration, per the hcp.The implantable neurostimulator (ins) looked good an appeared to be working.The hcp did state that the implantable neurostimulator (ins) may have depleted more quickly due to the open circuit, but it was reviewed that the open circuits typically don't deplete batteries rapidly.The ins was indicated for gastric stimulation/gastrointestinal/pelvic floor.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6303068
• MDR Text Key: 66546530
• Report Number: 3004209178-2017-02572
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2017

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: 07/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/05/2017
• Supplement Dates Manufacturer Received: 02/01/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 02/09/2016
• 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