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

Model Number 37800

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)() 2018, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 4351-35, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had the stimulator and leads implanted on the day of the report.During the case, they experienced some issues with the original leads and battery.They had to change out all of the devices because they could not get an impedance reading after multiple troubleshooting attempts.It was noted that they were reading out of range at > 20,000 ohms.They first tried a new battery and, when that didn¿t work, they opened and implanted two additional leads.The impedance reading was 462 and the patient was doing fine.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the leads (nht00083v and nht000837v) found no anomalies.The devices passed all testing in the laboratory and electrical testing of the leads determined continuity was complete.Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 4351-35, serial# (b)(4) ,implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Analysis results not available at this time.An additional report will be sent once analysis is completed.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7731603
• MDR Text Key: 115397596
• Report Number: 3004209178-2018-16921
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 11/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/03/2018; 08/24/2018; 08/08/2018
• Supplement Dates FDA Received: 08/15/2018; 08/28/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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
• Patient Age: 40 YR