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

Model Number 37800

Device Problem Malposition of Device (2616)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); Cognitive Changes (2551)

Event Date 06/29/2018

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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported there was an infection, drainage, and pain.It was noted the incision wound was opening.The patient noted the ins and leads were removed on (b)(6) 2018.The patient stated they thought the healthcare professional (hcp) did not know what they were doing.The patient noted on (b)(6) 2018 there was a nick in the intestine and an abscess in the abdomen.The patient reported she had the gastric pacemaker implant and the hcp nicked her intestine and she ended up with an abscess in her abdomen.The patient noted that something was catching on her rib and hurting.The patient stated the pacer box was not where it needed to be, and she needed to have it se down.The patient stated the pain went away and 2 weeks after she started to feel worse, delirious with fever, and their stomach hurt, and she didn¿t feel good.The patient noted she thought she had a bowel movement in bed, but it was pus rolling out of her, like (b)(6) and she went with the ambulance and went back to the hcp 2 days later and the hcp removed the device and leads out and left the lead incision open 5-6 inches long, 2 days later she went back and had 5 staples removed from the lead incision and pus was battling out.The patient reported the lead incision was 9 cm deep and blood was coming out and pus when the take gauss came off.It was noted the ins incision was healing and looked good.There were no further complications that have been 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: 8041613
• MDR Text Key: 126241118
• Report Number: 3004209178-2018-24751
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2018

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: 09/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/06/2018
• Date Device Manufactured: 04/05/2018
• 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: 45 YR