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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Erythema (1840); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that her incision was red and there was a bulge under and around the implantable neurostimulator (ins).This had occurred gradually but was present every day.The doctor had put her on antibiotics for the red incision.It had gone away but was back at the time of this report.The bulge was noted to have gotten bigger; it was about the size of an egg.When she would bend over, she'd get a charlie horse around her abdomen and it would take her breath away.She was in extreme pain when she would walk.The pain was from the belly button to the incision line.She couldn't even walk up the stairs.The incision being red had occurred on (b)(6) 2016 and the bulge had begun (b)(6) 2015.Additional information received from the healthcare provider (hcp) in response to follow-up reported that there was no obvious indication of an infection, but a precautionary antibiotic course was prescribed.The patient's complaints remained unchanged and the patient wanted surgical removal of the device.A removal was scheduled for (b)(6) 2016.No further follow-up was required.

Event Description

Additional information received from the consumer reported that there was nothing really wrong with the device, but their body was not accepting it.The implantable neurostimulator (ins) was removed on (b)(6) 2016.

• 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 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: 5476758
• MDR Text Key: 39566466
• Report Number: 3004209178-2016-03830
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Date Device Manufactured: 09/11/2015
• 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: 00028 YR