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

Model Number 37800

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.If information is provided in the future, a supplemental report will be issued.Attachment: [mw5073613.Pdf].

Event Description

The healthcare provider (hcp) reported via the user facility there was a revision on (b)(6) 2017 due to lead erosion and dysfunction of the device.The patient outcome was hospitalization.There were no further complications reported as a result of this event.

Manufacturer Narrative

(b)(4) were removed as they do not apply to this event.Information regarding the dysfunction in the previous submission was omitted as it does not apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare provider (hcp) reported via the user facility there was a revision on (b)(6) 2017 due to lead erosion.The patient outcome was hospitalization.There were no further complications reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type: lead.Life threatening was removed as it was incorrectly applied to this event.If information is provided in the future, a supplemental report will be issued.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7182749
• MDR Text Key: 96991771
• Report Number: 3007566237-2018-00136
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2018

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: 11/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 01/11/2018
• Date Device Manufactured: 05/14/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR