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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problems Erosion (1750); Internal Organ Perforation (1987)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 18-dec-2011, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 18-dec-2011, udi#: (b)(4), (b)(4) pertain to product id: 435135, nht011174n, product type: lead and product id: 435135, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient was having a battery change done and the doctor did an endoscopy during the procedure due to the impedance being out of range.It was found that both leads had migrated into the patient¿s stomach, and the leads were then removed.It was noted that there was an erosion.The hcp planned on implanting new leads and a battery in a few months after the patient healed.The issue was resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.- [(b)(4)].

Event Description

Additional information was received from a hcp via a user facility.It was reported that an esophagogastroduodenoscopy was performed so the leads could be cut endoscopically and removed.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that they could not ascertain the exact cause of the lead migration.They noted it was most likely a rare incorporation of foreign body by the gastric wall.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8852301
• MDR Text Key: 153067544
• Report Number: 3004209178-2019-14818
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2019
• Date Device Manufactured: 12/17/2009
• 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; Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 78