MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Skin Erosion (2075)

Event Date 01/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was implanted for gastric stimulation and gastrointestinal/ pelvic floor issues.The health care provider (hcp) reported that the patient had their device removed and replaced as the lead eroded into the patient's stomach.Her battery was also dead.No interventions or causes were 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.See manufacturer report 3007566237-2016-00782 for information on the patient's concomitant system.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5437129
• MDR Text Key: 38208545
• Report Number: 3007566237-2016-00783
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

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: 01/11/2007
• Device Model Number: 435135
• Device Catalogue Number: 435135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/15/2016
• 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): Required Intervention
• Patient Age: 00054 YR