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

Model Number 3116

Device Problem Impedance Problem (2950)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that one of the patient¿s electrodes eroded into the stomach as seen during endoscopy.Impedance testing was done and the impedance reading was greater than 800 ohms.It was noted, it was unknown which lead it was.The healthcare provider was planning to replace the whole system in a few weeks from the date of report.It was noted, the product issue was not resolved.The patient¿s status was reported as unable to obtain at the time of report.The patient had less than 50 percent therapy relief.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: 2009 (b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2009 (b)(6); product type lead.(b)(4).

Event Description

It was later reported that the manufacturer representative met with the doctor on (b)(6) 2014 and they were replacing the patient¿s leads and battery.It was noted that the patient started having a return of symptoms so they conducted an endoscopy several weeks prior to report.It was found that one of the patient¿s leads had eroded into their stomach so they were replacing both leads.The doctor was also going to replace the battery due to the patient¿s high settings and normal battery depletion.

Manufacturer Narrative

(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4133507
• MDR Text Key: 4790478
• Report Number: 3004209178-2014-18133
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2014

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: 07/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/20/2014; 06/09/2015
• Date Device Manufactured: 01/23/2013
• 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): Life Threatening; Required Intervention