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

Model Number 3116

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Vomiting (2144); Complaint, Ill-Defined (2331); Electric Shock (2554)

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 patient¿s friend/family member reported that the patient experienced shocking prior to cluster headaches.The change in therapy was not related to positional movements.The patient went to their healthcare provider and they had turned the device off.The patient had a fall about 2 days prior to the day of the report.The change in therapy/symptoms was reported to be sudden.The patient was in excruciating pain from the device.It was noted that without the device the patient was unable to eat.The patient also had nausea so bad they could not get it under control.The patient was vomiting.The patient¿s friend/family member stated that they had to put in tpn (total parenteral nutrition).The patient was diagnosed post implant with cluster headaches and was having arcuate leginfo.No further patient complications are anticipated or expected as a result of this event.

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; 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: 6807735
• MDR Text Key: 83156970
• Report Number: 3004209178-2017-17807
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• 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
• Report Date: 10/17/2017

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: 05/14/2014
• 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: 08/17/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 10/17/2017
• Date Device Manufactured: 11/15/2012
• 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