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

Model Number 37800

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 4351-35, lot#: nht034811n, implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 13-nov-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that per operative report done on (b)(6) 2021, patient was implanted with a new ipg and new lead.One of the previous leads implanted on (b)(6) 2018 was removed and replaced because it has a broken insulation.Per the report 1 lead with broken insulation within the subcutaneous pocket which was replaced.The disposition said awakened from anesthesia, extubated and taken to recovery room in a stable condition, having suffered no apparent untoward event.The condition was listed as doing well without problems.The technique was listed as after informed consent, patient was in the operating room and laid supine the operating table.Scd boots were placed, prophylactic antibiotics were administered.After induction of anesthesia, the abdomen was prepped and draped in the usual sterile fashion.A timeout was performed the patient and the procedure were identified correctly.After infiltration with quarter percent marcaine, the right lower quadrant subcutaneous pocket was opened and the previously placed gastric generator was identified.The pocket surrounding the generator was excised and the battery pack was removed.The leads were detached from the battery pack and upon examination of the leads, 1 lead had broken insulation.At this point we decided to replace the lead.Quarter percent marcaine with epinephrine was directed in the right upper quadrant area.A 5mm incision was made and with help of a 5-millimeter optiview trocar and 5 millimeter camera, the peritoneal cavity was accessed without any complications.Gas insufflation was started to pressure 15 mmhg.Under direct vision, a 5-millimeter trocar was placed in the supraumbilical position followed placement of the 12 millimeter trocar through the previously open subcutaneous pocket.The lead with a broken incision was identified and its insertion of the stomach was noted.The sutures holding the lead were cut and the adhesions were taken down using electrocautery.The lead was removed from the stomach and removed from the abdominal cavity.A new lead was brought into the field and the needle was passed intramuscularly in the position of the old lead.The position of the lead was checked with and endoscopy to make sure there was no full-thickness passage of the lead.The suture was then passed through the silicone bumper to anchor the leads in place.The lead was anchored using 2 ethibond sutures and the silicone bumper holding the tip of the lead was sutured in place using 2 ethibond sutures.The lead was in place, the trocars were removed and no bleeding was noted from he trocar sites.The lead was brought into the old subcutaneous pocket and was attached to a new gastric generator.The settings were checked and were noted to be 482 ohms for resistance.Patients old settings were reprogrammed into the new generator.The subcutaneous pocket was then closed with 3-0 vicryl suture and the skin with 4-0 monocryl.Dermabond was applied as dressing.Anesthesia was reversed and the patient was extubated and taken to pacu in stable condition.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# nht034811n serial# implanted: (b)(6) 2018 explanted: (b)(6) 2021 product type lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Additional information was received from a healthcare professional (hcp).The hcp reported that cause of the lead break was not determined.The most likely cause was possible repetitive bending at the fascia level as the lead was bent secondary to scarring around the lead.The steps taken were keep minimum length of lead in the subcutaneous pocket and avoid any acute bends in the lead when replacing the generator back in the pocket.

• 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
• MDR Report Key: 11886660
• MDR Text Key: 252715546
• Report Number: 3004209178-2021-08386
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 67