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

Model Number 3116

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 12/30/2013

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 04-oct-2015, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 07-nov-2015, udi#: (b)(4).(b)(4).Pertain to product id 4351-35 serial# (b)(4) product type lead and product id 4351-35 serial# (b)(4) product type lead.Occupation: non-healthcare professional.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).It was reported that since implant, the patient could feel the stimulation pulsation in their stomach, which caused pain to shoot to their left arm and shoulder.It was noted that the patient¿s healthcare provider (hcp) originally told the patient that the patient was just imagining it, but later the hcp told the patient that they started implanting the leads in the back of the stomach instead of the front because the front location was near a nerve and they found that stimulation delivered near that nerve would cause painful stimulation to the left arm area.The patient had the system replaced and the lead location revised from the front of the stomach to the rear; it was noted that the sensation stopped as soon as the hcp did this.No further complications were reported/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 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: 7763103
• MDR Text Key: 116448574
• Report Number: 3004209178-2018-17694
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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: 02/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 09/06/2013
• 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: 37 YR