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); Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

It was reported the patient¿s system was explanted due to leads eroding through stomach.An esophagogastroduodenoscopy was performed.The patient had recovered without permanent impairment.

Manufacturer Narrative

Concomitant products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type lead.(b)(4).

Manufacturer Narrative

Analysis of internal neurostimulator s/n (b)(4) found insignificant anomalies.Analysis of lead s/n (b)(4) found insignificant anomalies in the form of the product being cut through and segmented.Analysis of lead s/n (b)(4) found insignificant anomalies in the form of the product being cut through and segmented.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4237841
• MDR Text Key: 5062432
• Report Number: 3004209178-2014-21189
• 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: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• 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): Life Threatening; Required Intervention