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

Model Number 37800

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Nausea (1970); Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.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

The healthcare provider (hcp) reported via the manufacturer representative (rep) that upon explant of the leads and implantable neurostimulator (ins), they extracted two leads via a 12mm port.The scrub nurse visually looked at both leads upon extraction, and they were the same length.It was noted that hcp also performed a bariatric bypass at the same time.The next day, the patient needed a gastrografin exam.Upon exam, a retained piece of stretched plastic, described as a wire with silicon coating consistent with a gastric pacemaker, was noted in the muscle/fascia space.The plastic was removed.It was indicated that the issue was resolved.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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 lead was found in the intramuscular portion of the tract through the abdominal wall/left lower quadrant.This could not be seen intraperitoneally or subcutaneously during the previous operation.The lead was removed easily.There were no further complications reported as a result of this event.See attached medwatch documents.

Manufacturer Narrative

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

Event Description

The patient¿s healthcare provider reported that the patient was scheduled for an upper gi series due to nausea.The foreign body was overlaying the left abdomen measuring 13.5 cm in length.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: 6846516
• MDR Text Key: 85078490
• Report Number: 3004209178-2017-18851
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2017

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: 06/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 09/12/2017; 09/26/2017
• Supplement Dates FDA Received: 09/08/2017; 10/07/2017; 10/20/2017
• Date Device Manufactured: 01/07/2016
• 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: 53 YR