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

Model Number 3116

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 08/22/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015.(b)(4).

Event Description

The manufacturer representative reported receiving post-operative notes of a patient who was explanted on (b)(6) 2015.According to the operative notes, the patient developed sudden onset of left upper quadrant pain about 48 hours prior to the procedure.The patient presented with a white blood cell count elevation and a ct scan suggested that the leads had eroded into the gastric lumen.An endoscopy was performed and revealed that the entire lead along with the anchoring disk, both proximally and distally, and the titanium clips of both electrodes had eroded into the stomach.The two eroded gastric electrodes were retrieved.It was noted that this was chronic erosion that had happened over a significant period of time.The implantable neurostimulator was also explanted.The patient tolerated the procedure well and there were no complications.It was further noted by the health care provider that the device system was removed due to lead erosion causing infection.The patient's indication for use was gastrointestinal/pelvic floor.If additional information becomes available, a supplemental report will be filed.

• 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: 5098764
• MDR Text Key: 26593692
• Report Number: 3004209178-2015-18550
• 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
• Report Date: 08/27/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Date Device Manufactured: 11/15/2012
• 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
• Patient Age: 00055 YR