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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Discomfort (2330); Electric Shock (2554)

Event Date 12/04/2018

Event Type  malfunction  

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 sudden severe shocking/jolting/burning in the location of their stomach.It was noted that the issue started about 3 weeks ago and the doctor adjusted the ins and the patient had some relief, but the issue had worsened on the day of the report.The patient was redirected by the doctor to go to the er for pain relief.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 consumer via a manufacturer representative.It was reported that the patient had discomfort and shocking.The device was interrogated and the following values were observed: impedance 501, 4.5v, 9.0ma, 50hz,.5s on, 4s off, c<(>&<)>2 291, c<(>&<)>3 338, 2<(>&<)>3 503.It was noted that the battery was ok and the parameters were changed to a rate of 28hz, 1s on and 4s off.After this didn¿t help, the patient decided they wanted the device turned off until they could see their doctor for an abdominal x-ray and possible pocket revision.The issue was note resolved at the time of the report.No further complications were reported/anticipated.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported the device was malfunctioning.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

(b)(4) no longer applies to this event.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
• MDR Report Key: 8199460
• MDR Text Key: 131771546
• Report Number: 3004209178-2018-28414
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR