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

Model Number 37800

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The consumer reported that the patient had no therapeutic effect since implant and his symptoms worsened as of (b)(6) 2015.He was experiencing vomiting and bile was going up into his stomach.He had a three week check on (b)(6) 2015 and the healthcare provider (hcp) did not have a clinician programmer, but the hcp stated the implantable neurostimulator (ins) did not need to be checked.It was noted that the trial worked well.The consumer also mentioned that the patient's g-tube dislodged on (b)(6) 2015 and his j-tube dislodged two days after that.The consumer later reported that the patient was stuck in the hospital with an iv due to the issues.The hcp wanted a manufacturer representative (rep) to come out and check the status of the ins.Additional information received from the hcp reported that they were eventually able to check the ins and therapy was on.The ins was interrogated and the leads were checked, finding the impedances acceptable.The patient's feeding "jejunost" recently fell out and he had "colonic inenha" that required evaluation and treatment.The patient's indication for use was gastric stimulation.

Manufacturer Narrative

Upon further review, (b)(4) was determined to not be applicable.

Manufacturer Narrative

(b)(4).

Event Description

The healthcare provider (hcp) previously reported that the patient had colonic inertia that required evaluation and treatment.Additional information received from the consumer reported a loss of therapy as well as hospitalization for 34 days due to other complication with feeding tube and hospitalization for bowel shutting down and dislodged feeding tube.

Manufacturer Narrative

Duplicate event reported in #3007566237-2015-02426.Should have been reported under this manufacturing report.

Event Description

Additional information previously reported in manufacturing report #3007566237-2015-02426 (patient had been having "problems" and was currently in the hospital).If any additional information is received, a supplemental report will be filed under this manufacturing report number.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5064492
• MDR Text Key: 25278794
• Report Number: 3004209178-2015-17556
• Device Sequence Number: 1
• Product Code: LNQ
• 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,health professional
• Reporter Occupation: Other
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Date Device Manufactured: 06/16/2015
• 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): Hospitalization
• Patient Age: 00018 YR