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

Model Number 3116

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Battery Problem (2885); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that her ins battery was almost dead, and her insurance would not approve the replacement because they said it was an ¿investigational device¿.The patient reported that the ins settings had been changed unexpectedly, which happened maybe two years ago.The patient stated when she went to airports she requested to be ¿wanded down¿.The patient went in for a checkup after this and the hcp asked her who changed the setting, the patient stated no one had, so the patient believed the electromagnetic interference (emi) from the wand may have changed the settings.The patient noted the ins kept turning itself off.The patient stated this started happening last year and had happened three times.The patient noted they just went back in and they had it turned back on again.The patient noted she was careful to avoid emi if possibly, so she was unsure why it was happening.The patient stated they planned to continue to work with the hcp and field staff regarding ins replacement.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).They provided the patient¿s weight at the time of the event.They reported that they discussing ins replacement during the appointment on (b)(6) 2018 and it was replaced on (b)((6) 2018.They no longer had the old the device.The cause of the ins turning off by itself was not determined.No patient complications were reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7861396
• MDR Text Key: 121038670
• Report Number: 3004209178-2018-20267
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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: 03/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 07/05/2019
• Date Device Manufactured: 10/07/2011
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 39