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

Model Number 3116

Device Problems Break (1069); Unintended Collision (1429)

Patient Problems Hernia (2240); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# unknown, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: unknown, (b)(4) pertain to product id: 435135, serial# unknown, 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) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient had type i diabetes complicated by severe gastroparesis and gerd with be.The patient had had a fundoplication, pyloroplasty, and a gastric neurostimulator (gns) implantation in the past, and had developed a paraesophageal hernia with recurrent gerd and had fractured one of their gns leads; it was noted that this was all following a motor vehicle crash/collision (mvc).The patient¿s preoperative diagnosis included symptomatic paraesophageal hiatal hernia with recurrent gerd and diabetic gastroparesis.Procedures performed included: laparoscopic revision paraesophageal hiatal hernia repair with implantation of mesh reinforcement of the diaphragmatic closure; laparoscopic revision fundoplication; upper endoscopy; laparoscopic gns lead removal; laparoscopic gns lead implantation; and gns programming.It was noted that during the paraesophageal hiatal hernia repair, a 1 cm anterior enterotomy occurred and was closed.The broken lead was removed and replaced and the final gns settings were: impedance 388, current 5ma, and voltage 1.9v.It was noted that the patient tolerated the procedure well, there were no apparent complications, and the patient was transferred to recovery in stable condition.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 435135, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information was reported (the patient's weight was reported).

• 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: 7992006
• MDR Text Key: 124664769
• Report Number: 3004209178-2018-23615
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Date Device Manufactured: 05/17/2013
• 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: 44 YR
• Patient Weight: 66