MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); No Code Available (3191)

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 patient via a manufacturer representative regarding a patient implanted with a neurostimulator.It was reported that the patient was experiencing pain.Additional information was received from a healthcare professional via a manufacturer representative.It was reported that the patient was reporting intermittent abdominal spasms that occurred a few times a day when the device was on.When the device was turned off, the spasm would go away, but vomiting would return.The patient's device was implanted (b)(6) 2017.In (b)(6) of 2017, settings were 5 milliamperes (ma)/2.5 volts (v) on for 0.1 seconds (s) and off 5 s.It was noted that this was the nominal setting but with increased on/off time.In (b)(6) of 2017, settings were increased to 7.5 ma/3.7 v with increased on time of 0.3 s.In (b)(6) of 2018, settings were increased to 10 ma/5.3 v and increased on time of 1 s.In (b)(6) of 2018, settings were increased to 11.3 ma/6 v with increased on time of 1 s.The patient only reported the spasms to the surgeon in may, but the patient said they started getting spasms in (b)(6), but that over time the spasms had worsened.The patient had the device turned off for a week.Spasms disappeared, but vomiting returned and as a consequence of this, the patient had been remitted to the hospital as the patient's health deteriorated.The manufacturer representative suspected that stimulation was set too high and too long which could be causing the spasms to occur.Impedance values for the system were calculated based on the programming and was within normal range.It was noted that the programming was following the abell algorithm but went a bit higher with the current during the last programming session.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a healthcare professional and the manufacturer representative.It was reported that the healthcare professional asked the patient to provide and update on how they were doing over the week prior to (b)(6) 2018 with the settings of the pacemaker being lowered to before the patient felt the spasms.The patient's symptoms including nausea and vomiting had increased and they were unable to tolerate as much to eat because they were getting full quickly and then vomiting after.The patient was still getting the spasms even with the settings being reduced.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7794614
• MDR Text Key: 117568094
• Report Number: 3007566237-2018-02471
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/14/2018
• 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): Hospitalization