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

Model Number 37800

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event is an approximation.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 (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had three events where they felt a hot poker in their abdomen that dropped them to their knees.This happened another time, but not as bad.The hcp was going to see the patient on (b)(6) 2019.It was noted that no actions/interventions were taken at this point and the issue was not resolved.On (b)(6) 2019, it was reported that the ¿hot poker¿ issue was a sudden change.On (b)(6) 2019, the patient was seen and described a severe shocking sensation around their battery pocket site.The impedances were checked while they were sitting up and laying down and there was about a 150 point swing between the two (650 to 500).The patient also stated their abdomen was swollen, which the hcp witnessed.A decision was made to turn the device off for approximately 11 days to see if there was a difference in the shocking symptoms.Upon turning the device off, the patient noticed that their stomach returned to normal from bloating.They also noted that, after waking up from surgery, their nausea, vomiting, and pain symptoms were almost completely gone.They were doing exceptionally well until their first shocking symptoms, which had been occurring over the last few weeks prior to the report.The patient was going to be seen by a surgeon on (b)(6) 2019.No further complications were reported or anticipated.

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 gastric stimulator was turned off and the pain dissipated.It was noted that the patient was to return in 2 weeks to potentially restart the pacemaker.No further complications were reported/anticipated.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the cause for the sudden change in the ¿hot poker¿ sensation, shocking, and swing in impedance readings was not determined.The patient¿s battery was replaced on (b)(6) 2019; impedance was 421 and both leads were approximately 250 (c and 2, c and 3).The battery was turned back on at nominal settings.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 submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: analysis of the implantable neurostimlator (ins) (serial # (b)(6)) found insignificant anomalies; the ins passed functional testing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 8358712
• MDR Text Key: 137427323
• Report Number: 3004209178-2019-03706
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2019

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: 04/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 03/11/2019; 07/01/2019
• Supplement Dates FDA Received: 03/06/2019; 04/01/2019; 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 44