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

Model Number 37800

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Vomiting (2144); Numbness (2415); Electric Shock (2554); Bronchospasm (2598)

Event Date 10/24/2018

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) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was experiencing positional stocking/stimulation in her lower right quadrant.The rep noted after the hcp turned the device down to normal setting she was feeling more about the stomach.The hcp was going to the patient on october 30th to see if she was any better.The rep noted there was no environmental, external, or patient factors that may have led or contributed to the issue.The rep noted the issue was not resolved at the time of the report.It was noted there was surgical intervention and there was no surgical intervention planned.The patient was reported to be alive with no injury at the time of the report.

Manufacturer Narrative

Updated to serious injury.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) via the manufacture representative (rep) that reported the patient was doing much better.Additional information from the hcp via the rep (b)(4) reported the hcp planned on moving the battery within her current pocket above the incision line on (b)(4).Additional information from the hcp via the rep on (b)(4) reported the hcp revised the pocket on (b)(4) due to continued spasms.The patient was doing well in regard to elevating her nausea and vomiting symptoms.There were no further complications that have been 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 from the manufacture representative (rep) reported the issue had resolved.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Patient codes (b)(4) also pertains to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information from the healthcare professional (hcp) reported they saw the patient on october 29th and they were still experiencing pain and spams.The hcp had turned off her device on october 24th in hopes it would elevate the issue, but it did not.The hcp noted that everything during the surgery went perfectly but the patient had spasms in the left upper quadrant and feeling like she had shock waves, first numbness down the left leg and then across the abdomen.The hcp noted the implantable neurostimulator (ins) was on normal setting during this.The hcp noted they turned it off and she continued to have it happen.The hcp noted the ct of the abdomen and pelvic looked perfect.The hcp questioned if they should turn it back on or wait a bit.The hcp questioned if it was due to the actual stimulator being close to the rectus muscle causing spams.The hcp noted they couldn't imagine the probs themselves doing it.The hcp noted both themselves and the rep were perplexed.The hcp noted the patient was on gabapentin, but it had not made much of a difference.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep).They met with the patient and they stated they were no better since implant.The rep turned the device off to see if the patient¿s symptoms worsen.No further patient complications were reported as a result of this event.

• 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: 8010139
• MDR Text Key: 125868667
• Report Number: 3004209178-2018-24034
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/25/2019

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: 08/14/2019
• 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: 10/24/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 12/03/2018; 12/03/2018; 01/02/2019; 09/10/2019
• Supplement Dates FDA Received: 11/19/2018; 12/03/2018; 12/03/2018; 01/08/2019; 09/25/2019
• Date Device Manufactured: 02/23/2018
• 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): Required Intervention
• Patient Age: 25 YR