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

Model Number 37800

Device Problems Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type lead.Product id 435135, serial# (b)(4), implanted: (b)(6)2011, product type lead.(b)(4).Fdccodes: pertain to product id 37800, serial# (b)(4), product type implantable intestinal stimulator.(b)(4).Pertain to product id 435135, serial# (b)(4), product type lead and product id 435135, serial# (b)(4), product type lead.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that last summer, the patient needed to get their pacer replaced after having the battery for 6 years.The surgery went well until a few days after when the patient felt an electrical shocking sensation in their upper right breast (where the device was located), and the patient had more nausea than before.The patient went to their doctor who informed the patient that the leads had not been connected properly and so basically their body was receiving the electrical pulses instead of their stomach.The patient had corrective surgery about a week later on (b)(6) 2017.It was noted the setting read extremely high, the patient also had chronic pacer pocket pain that was only relieved when they physically lifted up their breast tissue and the pacer itself, and it was uncomfortable at best and unbearable at worst.It was noted that the surgeon believed the patient was still healing from the surgery, but the patient had several surgeries in the past and felt like this much pain for this long was unusual.No fur ther complications were reported/anticipated.

• 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: 7206457
• MDR Text Key: 97796064
• Report Number: 3004209178-2018-01019
• 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: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• Date Device Manufactured: 06/02/2017
• 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