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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431)

Patient Problems Pain (1994); Burning Sensation (2146); No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an im plantable neurostimulator (ins).It was reported that the patient experienced a complication where there was a miscommunication between the ins and leads.This required surgical repositioning on (b)(6) 2019.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2019, product type lead, product id 4351-35, serial# (b)(4), product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp).The caller provided the ins serial number and stated the patient was implanted on (b)(6).They stated the patient complained of pain and burning since surgery.The first documentation of misconnection between the lead and ins was on (b)(6) 2019.They clarified that the event was about a physical misconnection rather than miscommunication.The patient had a revision on (b)(6) 2019.They were not sure about the cause of the event.The patient has not been back in to the clinic so they were unsure about resolution.No further patient complications were 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 MN 00777 1200
• MDR Report Key: 9365223
• MDR Text Key: 172752248
• Report Number: 3007566237-2019-02414
• Device Sequence Number: 1
• Product Code: LNQ
• 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
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR