MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The consumer reported the device was not working.Cause, symptoms, troubleshooting, actions, and outcome remain unknown.The indications for use included urinary dysfunction and gas trointestinal/pelvic floor.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 4351-35, serial # (b)(4), implanted: (b)(6) 2013, product type lead; product id 4351-35, serial # (b)(46), implanted: (b)(6) 2013, product type lead.(b)(4).

Event Description

Additional information received from the consumer reported that the patient¿s stimulator turned down to factory setting on or around (b)(6) 2014.The patient went back to have the device adjusted and the nurse told the patient they adjusted the device, but did not know how to give the patient a printout.The patient ended up admitted in (b)(6) 2015.In (b)(6) 2015, the patient went to see the nurse at their health care provider's (hcp's) office for a device adjustment.In (b)(6) 2015, the patient again got no printout.The nurse told the patient they adjusted the device in (b)(6) 2014, january 2015, and (b)(6) 2015.The patient was in the hospital in (b)(6) 2015, and twice in (b)(6) 2015.The hcp did a gastric emptying scan (ges) and 50 percent of food was left in the patient.The patient went to their hcp¿s office in (b)(6) 2015 and the nurse adjusted the device.The step taken to resolve the event was that the patient had their stimulator adjusted 3 to 4 times since november.The symptoms the patient experienced were increased nausea, increased pain, increased distension, and ileus.

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 consume reported her symptoms became horrible in (b)(6) 2014 and more issues in (b)(6) 2015, and nothing was helping.She thought her device was working, but it happened that in (b)(6) 2014 the nurse turned the ins off because she did not know what she was doing and it was determined 11 months later that it was off.In (b)(6) 2015 her doctor said it was still 55 or 50% of food in her stomach.She thought the device batteries were dead.She went to the doctor and that was how they realized her device was off.The consumer said she did not know it was off, she was so sick and in the hospital so much with episodes of gi system shutting down.In (b)(6) 2016, she went back to another doctor who put the device in and they adjusted it.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 5288241
• MDR Text Key: 33749623
• Report Number: 3004209178-2015-24876
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2016

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: 02/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/17/2016; 12/28/2016
• Date Device Manufactured: 09/06/2013
• 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; Life Threatening
• Patient Age: 00056 YR