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

Model Number 37800

Device Problem Unintended Collision (1429)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); Staphylococcus Aureus (2058); Fluid Discharge (2686)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A healthcare provider reported they suspected a patient had an infection, but culture results have not returned from the lab at the time of the report.They said that shortly after a 2017 revision, the patient feel and their incision opened up.The patient went to the emergency room (er) where they sutured the incision to close it.Shortly after that on (b)(6) 2017 the patient had drainage from the ins site.The hcp removed the ins on (b)(6) 2017 and left the leads in the patient.The ins was replaced on (b)(6) 2017.On (b)(6) 2017 the patient was back in the office with drainage.The ins and leads were removed on (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 435135 lot# serial# (b)(4) implanted: 2012 (b)(6) explanted: product type lead product id 435135 lot# serial# (b)(4) implanted: 2012 (b)(6) explanted: product type lead product id neu_enterra_ins lot# serial# unknown implanted: explanted: product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare professional (hcp) reported that the device was discarded so the affected device was not available.The cause of the infections and drainage was determined to be staphylococcus aureus which was being treated with clindamycin 600 mg for 6 weeks.The patient fell shortly after the replacement on 2017 (b)(6) which opened up the incision site.On 2017 (b)(6), the patient continued to have serious drainage from the incision site.Debridement of skin, muscle and fascia for necrotizing infection with removal of mesh was done on 2017 (b)(6).The leads were preserved in the patient.On 2017 (b)(6), replacement surgery was performed in a new location.Leads were located and cleaned prior to attaching.There was a report that at the time the device was interrogated, programmed and there was no evidence of infection.On 2017 (b)(6), the patient had been doing well since replacement surgery on 2017 (b)(6).They were placed on augmentin for redness and drainage from incision site 1 week prior to office visit.The site continued to have drainage and now had a small opening in the middle of the wound.Surgery was done on 2017 (b)(6) to remove the device and leads due to infection.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: 2017-10-31 product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: (b)(6)2017 product type lead product id neu_enterra_ins lot# serial# unknown implanted: (b)(6)2017 explanted: (b)(6)2017 product type implantable neurostimulator if information is provided in the future, a supplemental report will be issued.

• 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: 7023372
• MDR Text Key: 91802330
• Report Number: 3004209178-2017-23578
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/15/2018

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: 02/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 11/22/2017; 08/10/2018
• Supplement Dates FDA Received: 12/06/2017; 12/11/2017; 08/15/2018
• Date Device Manufactured: 09/02/2016
• 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: 54 YR
• Patient Weight: 71