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

Model Number 3116

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 4351.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via the manufacturer representative (rep) reported that a gastroscopy procedure demasked a migrated lead tip into the stomach.Only a part of the lead tip was reported to be visible at the inner part of the gastric wall.A lead revision was planned but has not been scheduled.No symptoms or complications were associated with the event.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 4351, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that explant of one lead due to penetration of the stomach wall was planned.Implantation of a new lead was intended to be performed a few days after explant.It was required to replace the current lead with a plug.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 4351, lot# unknown, implanted: (b)(6) 2013, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the implant date of all components reported was (b)(6) 2013.Explant of lead was planned for (b)(6).No additional information was reported.No further complications were reported/anticipated.

Manufacturer Narrative

Device analysis for the lead (b)(4) revealed no significant anomaly.The lead body was cut through, product segmented.Electrical testing of the lead determined continuity was complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative reporting that the root cause of the lead migrating was unknown.The revision surgery was performed on (b)(6) 2018.Gastroscopy revealed a total tip migration into the stomach.The lead was cut into two pieces and explanted completely.The lead was replaced.The procedure ended without anything special to report.The same ins and other lead were still in use.

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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7565619
• MDR Text Key: 109936790
• Report Number: 3007566237-2018-01678
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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