MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Malaise (2359); Obstruction/Occlusion (2422)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 435135, serial# (b)(4), product type: lead.Product id: 435135, serial# (b)(4), product type: lead.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported they had surgery in (b)(6) 2017 because the wires from their implantable neurostimulator (ins) wrapped around their intestine.They continued to be sick and nauseated.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information reported that a ct scan of the lead wires from the device had wrapped around the patient¿s intestine and j-tube.The patient had a procedure to correct it.No further complications were reported/anticipated.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2007, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2007, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) indicated that the cause of the leads wrapping around the intestines was a chronic small bowel obstruction.The bowel obstruction was due to the torsion of the gastric pacemaker wires and adult malrotation and chronic small bowel and gastric dysmotility.They provided that surgery was performed as an intervention to resolve the issue.They conducted exploratory laparotomy, lysis of adhesions, and fixated the gastric pacemaker wires to the right of the hemidiaphragm.The issue was resolved.There were no further complications reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 6725919
• MDR Text Key: 80491459
• Report Number: 3004209178-2017-15157
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,Followup,Followup
• Report Date: 09/20/2017

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: 01/14/2016
• 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: 06/28/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 08/02/2017; 09/01/2017
• Supplement Dates FDA Received: 08/04/2017; 09/20/2017
• Date Device Manufactured: 07/23/2014
• 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
• Patient Age: 52 YR
• Patient Weight: 52