MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 06/05/2018

Event Type  Injury  

Event Description

It was reported on (b)(6) 2018 that the patient's vns site was infected and that she was admitted to the hospital.That day, the patient's generator and lead were explanted due to cellulitis.The patient was still in-patient the day after explant surgery.Approximately, two weeks later the patient reported that she was in pain and that signs of infection remained.The manufacturer's device history records of the lead and generator were reviewed.Sterility of the products were verified.Product return is not relevant as infection is not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.

Event Description

Operative notes from the patient's explant surgery indicated that upon opening the patient's incision that there was a murky yellow fluid that was aspirated out.The wounds were irrigated with bacitracin solution and packed with bacitracin-soaked gauze.No further relevant information has been received to date.

Event Description

It was reported that the patient had taken her bandage off a week after implant surgery.The patient indicated that it was itchy but that nothing was visibly wrong.Afterwards, she had food poisoning.She believed that her chest expanding during this caused her incision to open.She said that she had discharge leaking from the site and it smelled.However, when she followed up with the surgeon, he said that the incision site did not look bad and that they would watch it.The following day the incision still did not look right and it still smelled.She was prescribed bactrin.The next day the incision hurt, and the surgeon referred her for emergency explant surgery.Per clinic notes dated (b)(6) 2018, the patient's neck incision showed fair healing.It was reportedly still a bit red.The patient's chest incision still showed incomplete healing with redness and dried purulence, suggestive of infection no further relevant information has been received to date.

Manufacturer Narrative

(b)(4).Note that it was inadvertently not reported in supplemental mdr 2 that the information in describe event or problem was a correction and inadvertently not reported in supplemental mdr 1.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7688105
• MDR Text Key: 114002264
• Report Number: 1644487-2018-01189
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2019
• Device Model Number: 1000
• Device Lot Number: 204252
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR