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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Nausea (1970); Therapeutic Effects, Unexpected (2099); Weakness (2145)

Event Date 08/01/2016

Event Type  malfunction  

Event Description

The consumer reported that the patient had stomach pain, nausea, and was weak since (b)(6) 2016.The patient called the nurse at the health care provider's (hcp's) office and was told to call the manufacturer because the hcp was on vacation.The patient wanted to be reprogrammed.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the health care provider (hcp) reported that the cause of the lack of therapy was not determined.The troubleshooting performed related to the lack of therapy was that the hcp reprogrammed the stimulator on (b)(6) 2016.The diagnostics performed was that the hcp interrogated the stimulator and detected no problems.The action taken to resolve the lack of therapy was that the hcp reprogrammed the patient and they assumed it helped as they had not heard back from the patient.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5912187
• MDR Text Key: 53443490
• Report Number: 3004209178-2016-17761
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Date Device Manufactured: 07/15/2015
• 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 Age: 69 YR