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

Model Number 3116

Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Paresis (1998); Vomiting (2144); Therapeutic Response, Decreased (2271); Weight Changes (2607)

Event Date 04/01/2019

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) for the treatment of gastrointestinal/pelvic floor and gastric stimulation.It was reported that the hcp suspected the device was not working as the patient was vomiting, had a return of gastroparesis symptoms, and weight loss.They were hospitalized due to dehydration because of vomiting.The hcp checked the device and it showed 10v, pw330, rate 14 cycling.1 on and 5 off, impedance of 488 ohms.The hcp stated they suspected lead dysfunction but the impedances looked good.The longevity measurement showed >120 months.Usage showed 8738 hours and the use % showed ???.The hcp turned off the therapy for a brief moment and turned it back on.The patient did not have any falls or trauma.The hcp added that the patient had low blood pressure.They stated they would adjust the settings and see the patient the following week and consider this a flare.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Additional review indicated (b)(4)is no longer applicable to the event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp).It was reported that the patient¿s implantable neurostimulator (ins) had reached an end of service (eos) battery status.The hcp clarified that there was no alleged defect against the ins or leads.The hcp stated that they spoke with a manufacturer representative who told them that the device would stop working once it reaches an eos battery status.The hcp reported that the patient had their ins replaced about a week later after the date of the original report, around (b)(6)2019, and that they were doing much better.It was noted that the issue was resolved and the status of the explanted device was unknown.No further complications were reported or anticipated.

• 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: 8764457
• MDR Text Key: 150143418
• Report Number: 3004209178-2019-13000
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Date Device Manufactured: 08/31/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR