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

Model Number 3116

Device Problems Break (1069); Degraded (1153); Disconnection (1171); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Event Description

It was reported that a patient¿s lead broke in (b)(6) 2014.She had gone down tube slides, jumped off a diving board, went down a spiraling tub slide and hit her stomach on the tub.The leads completely came off the implantable neurostimulator (ins) and were corroded.She had emergency surgery to repair the lead and had a big scar from the surgery.Not all parts of the lead were explanted and the location of the lead issue was the connection between the lead and the ins.The patient¿s outcome was unknown and she had not returned to her healthcare provider for follow-up.

Manufacturer Narrative

Concomitant product: product id 435135, serial # (b)(4), implanted: (b)(6) 2012, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2012, 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: 4650065
• MDR Text Key: 5617137
• Report Number: 3004209178-2015-05811
• 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
• Report Date: 03/11/2015

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: 02/28/2014
• 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: 03/11/2015
• Initial Date FDA Received: 04/01/2015
• Date Device Manufactured: 08/29/2012
• 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