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

Model Number 1000

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

A nurse practitioner reported that she received a high impedance reading when running system diagnostics.High impedance was present during patient's previous appointment as well.Patient was referred to neurosurgery but the patient was sent back to for evaluation.X-rays were ordered.Patient underwent surgery for high impedance.The lead pin was re-inserted but the high impedance was still present.Surgeon noted fluid in the generator header.During the process of cleaning the fluid from the header and re-inserting the lead pin, the diagnostic test was re-run and the high impedance was still present.The lead pin was removed again to attach a new generator, at which time the septum plug came out of the generator header.When the surgeon went to unscrew the lead from the generator, the silicon septum plug came out of the screw head.It was stated that the area was cleaned out and rechecked and there was still high impedance.The generator was replaced and the high impedance was resolved upon diagnostic testing.The lead was not replaced.The suspect generator has not been received to date.

Event Description

Review of programming data found that the high impedance resolved on date of surgery; however, per attending company representative, this resolution of high impedance was likely due to use of the test resistor pin and not pin re-insertion.No further relevant information has been received to date.

Event Description

A review of device history records for the generator shows that no unresolved non-conformances were found.Company representative reported that the surgeon had attempted proper pin insertion thrice during the surgery.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction.Existing recommendations, as described in the physician¿s manual, should still be followed.Additional investigation is underway.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7987521
• MDR Text Key: 124529008
• Report Number: 1644487-2018-01877
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2020
• Device Model Number: 1000
• Device Lot Number: 204389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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 Age: 50 YR