MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

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

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Anxiety (2328); Abdominal Distention (2601)

Event Date 08/19/2016

Event Type  malfunction  

Event Description

The health care provider (hcp) reported that the patient felt bloated and felt a tingling or prickling sensation in the stomach every 15 seconds.This was due to a sudden change in therapy or symptoms.This began on (b)(6) 2016 after a porta-cath for weekly nutrition treatments.The patient was in moderate pain 5 or 6 level out of 10.The patient didn't think their stimulation was on due to that they could not feel it.The indication for use for this patient was gastric stimulation.

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

Additional information was received from a health care provider (hcp).It was reported that the patient was concerned that the stimulation had been deactivated by an unrelated procedure, but when the device was interrogated, it was found to be functional.It was also stated that the actions/interventions taken to resolve the patient not thinking stimulation was on included increasing the voltage from 5.0 volts to 7.5 volts.The hcp also noted that the cause of the previously reported issues appeared to be anxiety that was alleviated when the device was interrogated; the issues were resolved.

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

Additional information reported that after having a ¿power port¿ put in their ins was reset and they had to see their healthcare provider to have their device reprogrammed.The patient noted that they were informed that their device did not need to be turned off prior to the procedure.The patient stated that the reprogramming had resolved their issue.No further complications reported and/or anticipated.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 5943491
• MDR Text Key: 54465863
• Report Number: 3004209178-2016-18716
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2017

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: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/17/2017
• Supplement Dates FDA Received: 10/21/2016; 05/16/2017; 09/25/2017
• Date Device Manufactured: 06/26/2015
• 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 Age: 48 YR