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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437); Battery Problem (2885); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 08/11/2019

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 consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that last week, the patient felt the stimulator ¿like when an engine is trying to start up¿ make a revving noise, ¿then it started getting warm where the ins was¿.It was noted that this occurred 3-4 times ¿like it was trying to push power but it just wouldn¿t go and got really hot.The patient usually could feel the stimulation but no longer felt the stimulation working after that.It was confirmed that there were no falls/traumas that could be related to the issue.The patient contacted their healthcare provider (hcp), and was redirected at the time of the report to follow up with their hcp to assist with checking the ins.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) via a manufacturer representative.It was reported that there was an error message on the clinician programmer of: out of range, delivery amplitude lower than programmed likely because of low impedance.It was noted that the impedance was 502 ohms, but it was unknown which pair the impedance was taken from.Troubleshooting at the time of the report was not possible due to a lack of access to the product.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) via a manufacturer representative and from a consumer.It was reported that the device stopped working and the patient was having surgery on monday (b)(6) 2019.It was noted that the patient was just going into the kitchen and it got really hot then it stopped working.The stimulator was evaluated with a programmer on (b)(6) 2019 and was found to have turned itself off.It was noted that there was an error message of ¿out of regulation.Delivered amplitude is lower than the programmed¿likely because of low impedance¿.The impedance was measured at 502.52 and it was concluded that the battery was wearing out, and the patient was scheduled for a replacement.It was reported that the cause of the event was the battery having failed and turned off the programmed stimulation.It was noted that the patient required high settings and had needed frequent battery generator changes in the past.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information was reported.

Manufacturer Narrative

Product id: neu_wrench_acc, lot# unknown, product type: accessory; product id: 8840, serial# unknown, product type: programmer, physician.Analysis of the ins ((b)(4)) found no significant anomalies.The ins was subjected to a series of standard tests that included, but was not limited to, visual inspection, output and telemetry testing, and functional testing.Analysis determined that the ins output and telemetry were acceptable; however, the battery was near normal battery depletion.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: 8920598
• MDR Text Key: 155196268
• Report Number: 3004209178-2019-16142
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/03/2019

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: 06/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 08/28/2019; 09/03/2019; 09/16/2019; 11/26/2019
• Supplement Dates FDA Received: 09/03/2019; 09/13/2019; 09/20/2019; 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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: 51 YR