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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Twitching (2172); Electric Shock (2554)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(6), implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from a healthcare professional (hcp) via a manufacturer representative reported that two (2) weeks after implantation of the implantable neurostimulator (ins), the consumer began experiencing ¿twitching and a very slight shocking sensation¿ behind her other implantable device/pump.It was also noted that the consumer was quite highly statically charged and regularly gets electric shocks from clothing, etc., which could be connected to her eds condition.No troubleshooting was required as both the consumer and the hcp were not concerned about the twitching, as the hcp believed the pump could be sitting next to a small nerve because it only happened in certain positions.No interventions were planned.Additional information received reported the pump was implanted in the lower abdomen, and ins in left upper abdomen (extra-peritoneal).The devices were 10 cm at nearest points, the consumer was very tiny.The consumer was happy with both therapies.The sensation did disappear when the pump was turned off, and had not tried turning off the ins yet.There were no further complications reported and/or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received reported the cause of the twitching and slight shocking sensation were unknown, and the consumer suspected possible electrical connection between the two devices.Both devices remain implanted and the consumer was using both.It was noted that there were no further complications, though twitching was still present.

Manufacturer Narrative

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

Event Description

Additional information received reported that they did try turning off the ins, and when turned off temporarily by the representative, the twitching did stop.It was noted that it was recommended to use the therapy as the consumer required it.It was also noted that the doctor was not concerned with the twitching.

Manufacturer Narrative

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

Event Description

Additional information received from the patient through a manufacturer representative reported they had ¿started experiencing ongoing issues¿ with the ins ¿sending painful electric shocks through her abdominal wall across to¿ her pump after the ins was implanted in 2016.It was stated that the ins was conducting electrical shocks to the patient¿s pump.Despite the patient¿s issue, she noted that she loved her device and that it ¿greatly improved her quality of life.¿ there were no surgical interventions planned or performed.Though the issue remained unresolved at the time of report, the ins remained implanted and in service.No further complications were reported or anticipated.Please see manufacturer report #3004209178-2017-19753 for information regarding the patient¿s pump.

Manufacturer Narrative

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

Event Description

Additional information received from the patient through a manufacturer representative reported they had ¿started experiencing ongoing issues¿ with the ins ¿sending painful electric shocks through her abdominal wall across to¿ her pump after the ins was implanted in 2016.It was stated that the ins was conducting electrical shocks to the patient¿s pump.Despite the patient¿s issue, she noted that she loved her device and that it ¿greatly improved her quality of life.¿ there were no surgical interventions planned or performed.Though the issue remained unresolved at the time of report, the ins remained implanted and in service.No further complications were reported or anticipated.Please see manufacturer report #3004209178-2017-19753 for information regarding the patient¿s pump.

Manufacturer Narrative

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

Event Description

Additional information received from the patient through a manufacturer representative reported they had met with their hcp the day prior to follow-up and was told that there was a way they ¿might be able to insulate the stomach by wrapping the omentum around it¿ and that this would ¿be less likely to conduct electricity through¿ to their implanted pump.The patient noted that they would ¿probably have the surgery done either way as the jolts behind the pump were quite painful.¿ it was further noted the surgery timing would depend on whether it was the ins that had damaged the pump or if it was something unrelated and that if it was the ins, that they ¿would probably have the surgery sooner rather than later to avoid a repeat failure.¿ the patient¿s hcp told the patient that he could ¿potentially do the surgery in a fortnight.¿ the patient planned to reach to her gastric consult still as of (b)(6) 2018.

• 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: 7088023
• MDR Text Key: 94929535
• Report Number: 3004209178-2017-24955
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup,Followup
• Report Date: 02/22/2019

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: 08/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 01/11/2018; 08/27/2018; 01/25/2019; 01/25/2019
• Supplement Dates FDA Received: 01/18/2018; 01/31/2018; 09/21/2018; 02/20/2019; 02/22/2019
• Date Device Manufactured: 03/07/2016
• 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 Age: 32 YR
• Patient Weight: 50