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

Model Number 37800

Device Problems High impedance (1291); Connection Problem (2900); Impedance Problem (2950)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The healthcare provider (hcp) reported via the manufacturer representative (rep) that during the 4-6 week post-implant follow-up appointment, the patient's impedance was out of range and greater than 800.It was unknown what factors may have led to this issue.The hcp was thinking of taking the patient back to the operating room to retighten the set screws.The issue was not resolved at the time report.There were no further complications reported as a result of this event.

Manufacturer Narrative

Additional information stated that the original report had the wrong patient information.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a rep.It was reported that the patient had a revision done on the battery/pocket on the day of the report.The lead was removed, wiped off, and screwed back down.The impedance dropped to 503 and the rep stated "all is well".

Manufacturer Narrative

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

Event Description

Additional information from the manufacture representative (rep) on september 18th reported the patient was implanted on (b)(6) , 2018.The rep noted the issue was recorded 4-6 weeks post implant, the set screw was loose.The rep noted they spoke to the nurse who looked up the patient¿s information in the chart.There were no further complications that have been reported as a result of this event.

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: 7715723
• MDR Text Key: 115069716
• Report Number: 3004209178-2018-16522
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 03/28/2019
• 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: 07/12/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 08/08/2018; 09/18/2018
• Supplement Dates FDA Received: 09/11/2018; 10/02/2018; 10/05/2018
• Date Device Manufactured: 10/12/2017
• 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: 53 YR