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); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144)

Event Date 06/01/2016

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

Information was received from a consumer and a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation and gastrointestinal/pelvic floor.It was reported the patient was currently in the hospital and would like to have a manufacturer representative (rep) check their gastric stimulator because it had gotten "messed up" by the tsa at the airport and was turned off.The patient also reported they had been vomiting on/off, had a gi bleed, they were giving them blood and it was dumping into the spleen.They also mentioned they had non-alcoholic cirrhosis which was caused by their gastroparesis and walked around with a water bottle constantly.The change in therapy/symptoms was reported to have been sudden in nature.The patient was to follow up with the hospital staff in order to have a rep check their device.The patient also mentioned they would like to possibly pursue having a spinal cord stimulator or pump device implanted for degenerative disc.The patient noted they had a step dad who had a manufacturer defibrillator implanted who passed away, however they confirmed the death was not related to the defibrillator.The hcp later reported the patient had nausea and stomach pain, and requested a rep be paged.It was noted the patient had been admitted to the hospital on (b)(6) 2016.

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: 5785765
• MDR Text Key: 49281511
• Report Number: 3004209178-2016-14010
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

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: 03/28/2013
• 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: 06/20/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: 06/20/2016
• Supplement Dates FDA Received: 09/24/2017
• 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): Hospitalization
• Patient Age: 59 YR