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

Model Number 3116

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193); Ambulation Difficulties (2544)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

It was reported that for the ¿last day and a half¿ the patient had severe abdominal pain and was on her way to the emergency room (er).The patient felt a lead was disconnected.The patient could hardly walk and the pain shot up into her stomach, ¿it did not matter what she did.¿ the patient felt that stimulation was not feeling right.The patient stated that ¿it had been a day and a half and she felt like she was having a baby.¿ the patient clarified that she had cramping and blood in her stool.The patient stated that ¿she thought if she just pooped she would feel better, but the pain actually got worse.¿ additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative

Concomitant products: product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type lead; product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type lead.(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: 3868776
• MDR Text Key: 4455051
• Report Number: 3004209178-2014-11459
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2014

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: 10/14/2014
• 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: 05/23/2014
• Initial Date FDA Received: 06/12/2014
• Date Device Manufactured: 04/16/2013
• 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 Age: 00045 YR