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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported the patient started throwing up around christmas.It was stated the patient went to their healthcare provider (hcp) to have the device checked.It was determined that the device was shut off and ¿some sources¿ of electromagnetic interference (emi) was suspected.This was reportedly the first time the device had turned off in five years as the patient always followed the rules regarding emi.Different sources of emi and magnets were reviewed, but a remote controlled helicopter was suspected to be the cause of shutting the device off.The patient started using the helicopter around christmas which was when the patient noticed a return of symptoms.The device was turned back on and the settings were the same as they used to be.Cycling settings were changed and a battery longevity calculation showed the patient had 110 hours left.The hcp reportedly told the patient to ¿not trust¿ the longevity reading from the ¿hcp¿s meter.¿ it was stated the patient¿s device should have been dead in october, but it was not.Those readings were reported to be ¿a little bit off.¿ about two weeks later, it was stated the patient had received assistance from their doctor or manufacturer representative and their concerns were resolved.An appointment on (b)(6) 2014 via phone with the doctor and representative was noted.

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.(b)(4).

• 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: 3596725
• MDR Text Key: 4091175
• Report Number: 3004209178-2014-01308
• 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
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2010
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2014
• Date Device Manufactured: 11/15/2008
• 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