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

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Pain (1994); Urinary Retention (2119); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 08/31/2016

Event Type  Injury  

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

The consumer and manufacturer representative reported that the patient had a loss of therapy on (b)(6) 2016.The patient had a return of symptoms including severe abdominal and back pain, vomiting, and couldn¿t go to the bathroom.The patient went to the hospital on (b)(6) 2016 and had been there since.The manufacturer representative came on (b)(6) 2016 and checked the battery and it was dead.They were going to stabilize the patient and transfer them to a different department to take care of the device.The patient had been stabilized and moved, but now they weren¿t doing anything about the device and they wanted to talk to the manufacturer representative.The manufacturer representative reported that the hospital the patient was at could not do the implant and it would need to be done at another facility.On (b)(6) 2016, the patient was waiting for a bed at another hospital.The indication for use for this patient was gastric stimulation.

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 consumer reported that the circumstance that led to the depleted battery was that the patient got very sick in the hospital.The step taken to resolve the depleted battery was that the patient was transported to a different hospital to have surgery performed.The depleted battery had been resolved.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5978689
• MDR Text Key: 55668826
• Report Number: 3004209178-2016-19746
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2016

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: 08/28/2011
• 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: 09/07/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; 10/20/2016
• Supplement Dates FDA Received: 11/09/2016; 09/26/2017
• Date Device Manufactured: 03/02/2010
• 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; Required Intervention
• Patient Age: 42 YR