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

Model Number 37800

Device Problems Premature Discharge of Battery (1057); No Device Output (1435)

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

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that the hcp tried to interrogate the patient¿s device and when they checked, the ins was off; the hcp tried to turn it back on and the programmer would not allow the stimulation to turn on.It was noted that the hcp was getting an error message and the manufacturer representative thought the message may have referred to an eos.The therapy parameters were 5v, 8.8ma, 330us, 110hz, 3s 1s off.It was noted the manufacturer representative would follow up with the hcp to verify the battery status and review information.No patient symptoms were reported.Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that it was unknown exactly what the message was, but the hcp confirmed there was a message indicating low battery life, and the cause of the message was determined by the hcp to be due to normal use.The hcp confirmed the patient would be scheduled for a replacement.Information was received from a healthcare professional (hcp) via manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient¿s battery was dead and the battery life ended pre-maturely.The rep noted it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the event.The rep noted it was unknown what diagnostics or troubleshooting was done related to the event.The rep noted the battery was replaced on (b)(6) 2019 and the issue was resolved at the time of the report.The patient was listed as alive with no injury at the time of the report.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Analysis of the ins (b)(4) found that the ins battery was at normal end of life.The telemetry and output tested okay.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis determined that the implantable neurostimulator (ins) output and telemetry were acceptable; however, the battery was near normal battery depletion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis results were not available at the time of this report.An additional report will be sent when 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: 8247663
• MDR Text Key: 133050686
• Report Number: 3004209178-2019-00985
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• 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
• Patient Age: 40 YR