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

Model Number 3116

Device Problems Break (1069); Disconnection (1171); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)

Patient Problems Abdominal Pain (1685); Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Abdominal Distention (2601)

Event Date 03/13/2018

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 healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had increased abdominal distension, nausea, vomiting, and abdominal pain; it was noted that these symptoms were sudden in onset.The patient was hooked to an ekg and did not see a signal.It was noted the doctor saw a discontinuity at l1.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).The patient was no longer in the emergency department and had been discharged (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 435135, lot# unknown, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient presented to the clinic with failure of their gastric stimulator.The hcp stated that, for the last few months, the patient could tell that the pace on the stimulator was slowing down as they were regaining some symptoms of nausea after eating.Also, the patient worked in an er and had a history of hooking themselves up to an ekg monitor to see if the pace was still there.On (b)(6) 2018, the patient was working and didn't see a signal on the ekg monitor, which correlated with their new onset of symptoms.The device ended up being replaced on (b)(6) 2018.During the surgery, they found the lead was completely disconnected and appeared to be cut off from the intra-abdominal side.This lead was completely replaced as well.

• 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: 7342006
• MDR Text Key: 102501791
• Report Number: 3004209178-2018-05090
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 04/17/2013
• 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: 50 YR
• Patient Weight: 84