MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

Information was received from a manufacturer¿s representative and it was reported that a potential expired lead was implanted in a patient.No patient symptoms reported.There were no complications or that no further complications were reported/ anticipated.

Manufacturer Narrative

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

• Brand Name: NEU_ENTERRA_INS
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6429272
• MDR Text Key: 70774399
• Report Number: 3007566237-2017-01095
• Device Sequence Number: 1
• Product Code: LNQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• 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