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

Model Number 37800

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Material Deformation (2976)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that they had their device turned off because they felt electrical waves and vibrations in their stomach where the implant was located.They stated that they started feeling this sensation on (b)(6) 2017, and the nurse turned the device off on (b)(6) 2017.The patient was still feeling the stimulation after it was turned off.They felt it more when they were mobile.Further information received from the patient indicated that they thought the leads may have gotten twisted during surgery because they had been feeling electrical shocks since (b)(6) 2017.They wanted to know if this should have been corrected before they were "closed" up.The patient stated that the implantable neurostimulator (ins) was turned off on (b)(6) 2017 due to the shocking.These dates contradicted the dates the patient originally provided.It was indicated that although the device was still off, the patient was still feeling the shocks.They mentioned that their spouse saw the x-rays with the doctor, and the spouse believed the doctor said that the leads were twisted.The patient was schedule to have x-rays taken and meet with their managing doctor on (b)(6) 2017.There were no further complications reported as a result of this event.

Manufacturer Narrative

Device codes are no longer applicable to the event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a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.

Event Description

Additional information from the healthcare provider (hcp) reported that a plain film of the abdomen showed the leads were not twisted.They stated that the shocking was not applicable.They left the device because of the shocking but the patient still felt shocking after the device was turned off.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the device was turned off for a week and the patient got worse, so they turned it back on.It was noted that the doctor and the patient did not know why the device was working, so they are waiting for approval to run some testing.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the patient¿s device was not working and also that they felt like there was a vibration and shock.No further complications were reported/anticipated.

• 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: 7072311
• MDR Text Key: 93842426
• Report Number: 3004209178-2017-24640
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2018

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: 02/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/14/2017; 02/02/2018; 02/20/2018
• Supplement Dates FDA Received: 12/15/2017; 02/07/2018; 03/12/2018
• Date Device Manufactured: 08/15/2017
• 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 Age: 38 YR
• Patient Weight: 88