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

Model Number 37800

Device Problem Unstable (1667)

Patient Problems Staphylococcus Aureus (2058); Swelling (2091); Urinary Retention (2119); Complaint, Ill-Defined (2331)

Event Date 12/06/2017

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) for gastrointestinal/pelvic floor issues.It was reported that at the patient¿s last implant, the surgeon did it outpatient (had always been inpatient), and the patient¿s friend/family member didn't think the surgery was done properly and thought a pocket was not made or the ins was not sewn in because the ins was moving around and around the ribs, maybe turned where it was wider/stuck out more, and was sticking out farther than the previous devices.The past implants were replaced due to normal battery depletion.It was noted that that the patient had problems after the surgery as well, including a little swelling and not draining; they followed up with the surgeon and eventually went to the er to have tests run/blood test to check for a staph infection.It was noted that the swelling subsided and that the patient had staph one time before at a back surgery that was unrelated to the implant.It was noted that there was not an issue with the therapy.No further complications were reported/anticipated.

Manufacturer Narrative

Due to (b)(6) harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported since the implant the device had not been checked and the patient was not emptying properly.The patient felt the surgeon did not implant the device right.The patient noted they had been going through a lot of problems.The patient stated they sent her home without checking if she could go to the bathroom and it caused many problems.The patient stated the surgery was a messed-up surgery.The patient noted they didn¿t know what was wrong with her.The patient stated she was the first patient for the surgeon and he didn¿t know what he was doing.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: 7211194
• MDR Text Key: 97942534
• Report Number: 3004209178-2018-01152
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2018
• Date Device Manufactured: 09/15/2017
• 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 Outcome(s): Other
• Patient Age: 56 YR