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

Model Number 37800

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 01/01/2018

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) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the hcp saw a por with a code of 0x0 on the clinician programmer screen.The hcp moved forward through the screens and updated the date and time and interrogated the ins again and it then came up with eos (end of service).It was noted that there was an allegation/dissatisfaction with the ins longevity as the ins was just replaced in (b)(6) 2017.There were no traumas/falls that could be related to the issue.The patient had symptoms in the abdomen, felt that stimulation was turned off for the past 2 weeks, and they had not been feel well for (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) indicated that they noticed an increase in nausea/vomiting, and the patient couldn't "feel" the stimulator anymore.They checked the battery status, and it was dead after one year.There were no further complications reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient¿s device was replaced on (b)(6) 16 and not (b)(6) 2017.The patient called when they felt it had been long enough and it needed to be interrogated; the battery was checked on (b)(4) and scheduled for a battery change on (b)(4).It was noted that the readings were retook multiple times.It was noted that the cause of the por and eos messages was that the battery was dead or no longer functioning.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the ins (b)(4) revealed that the output and telemetry were acceptable; however, the battery is near normal battery depletion.There was good, stable output on the electrode pairs the ins had when it was received and good, stable output on all pairs.There were no issues when pressing on the ins can.A computer longevity estimate was completed based on the parameters the device had when it was received for analysis.The information obtained indicated that the device had reached eos (end of service).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: 7259585
• MDR Text Key: 99925835
• Report Number: 3004209178-2018-02977
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2018

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: 11/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/12/2018; 03/20/2018; 05/04/2018
• Supplement Dates FDA Received: 03/06/2018; 03/26/2018; 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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
• Patient Weight: 66