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

Model Number 37800

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported they went to their appointment, the day prior to the report, and the healthcare provider (hcp) reported that something was wrong with one of the leads.The hcp wanted to do an esophagogastroduodenoscopy (egd) to find out if a lead had come loose or if it was a faulty wire.At the appointment, the patient said their device was working and the healthcare provider (hcp) was able to adjust them.One lead was showing as not functioning.The patient would follow up with their hcp.No further complications were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) provided the following results of an impedance check: c <(>&<)> 2=20 ,000, c <(>&<)> 3=3 333, 2 <(>&<)> 3=3 20,000.The results of 2,3 were greater than 4000 ohms.Patient services helped the hcp reprogram to c <(>&<)> 3, and suggested an x-ray for the lead.The hcp was going to discuss a possible revision with the patient.The patient wanted a revision because they believed the warranty would not be available to them.There were no symptoms or complications reported as a result of this event.

Manufacturer Narrative

It was initially reported that c<(>&<)>3=3333.This value was incorrect.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) provided the following results of an impedance check: c <(>&<)> 2=20 ,000, c <(>&<)> 3=333, 2 <(>&<)> 3=3 20,000.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6501293
• MDR Text Key: 73102692
• Report Number: 3004209178-2017-08534
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/07/2017
• Supplement Dates FDA Received: 06/07/2017; 06/07/2017; 10/03/2017
• Date Device Manufactured: 07/13/2016
• 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 Age: 45 YR