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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 4351-35, serial/lot #: nht033253n, ubd: (b)(6) 2019, udi#: (b)(4).Analysis results not available at this time.An additional report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the system was removed on (b)(6) 2018 because the patient had a history of shocking sensation from the device and wasn't getting therapy value.The patient recovered without sequela.No further complications were reported or anticipated.

Manufacturer Narrative

Continuation: product id 4351-35 lot# serial# (b)(4) implanted: explanted: 2018 (b)(6) product type lead product id 4351-35 lot# serial# (b)(4) implanted: explanted: 2018 (b)(6) product type lead product id 4351-35 lot# serial# (b)(4) implanted: explanted: 2018 (b)(6) product type lead product id 4351-35 lot# serial# (b)(4) implanted: explanted: 2018 (b)(6) 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 shocking was first notice on 2017 (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (serial # (b)(4)) revealed good stable output on all electrode pairs the ins had when it was received, and telemetry was acceptable.A connector block leakage test was performed and normal impedances were observed, indicating there were no electrical leakage paths in the connector area.The ins passed functional testing.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: 7739291
• MDR Text Key: 115693694
• Report Number: 3004209178-2018-17138
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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: 23 YR
• Patient Weight: 59