MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 300

Model Number 300-20

Device Problems Detachment Of Device Component (1104); High impedance (1291)

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

Event Date 04/23/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on a patient¿s device.It was stated that the patient was receiving a prophylactic generator replacement, but when the new generator was attached high impedance >10,000 ohms was seen.The pin was re-inserted, the generator was re-positioned, but high impedance was still seen on the new device which was stated to be a m104.Therefore the patient¿s lead was re-inserted into the old generator to test high impedance, and it was stated that the impedance value was normal.Generator diagnostics were reported to have been performed on the new generator using the test resistor, and everything was ok.It was found through a download of data that generator diagnostics were not performed but system diagnostics with the test resistor were performed and showed ok impedance.Therefore they re-inserted the lead into the generator again and high impedance was still seen (>10,000 ohms).They opened another m104 and inserted the lead into this device, and high impedance was still seen.They were told to re-insert the pin, and they did, and high impedance was seen again.They then removed the lead and used the test resistor to run generator diagnostics (again was system diagnostics with a 4kohm test resistor), which indicated that everything was ok with the generator.At this point it was confirmed that the lead was the issue, and previous data shows that the lead had been implanted for 24 years.There was no back-up lead available for implant, and therefore the doctor decided to re-implant the old device m104 which the patient was previously implanted with since it was previously not showing the high impedance.They will then have to schedule the patient for a full revision surgery.Based on the data download information, it appears that sometime between line 5 (time 8:44:03) and line 9 (time 9:00:42) there may have been damaged caused to the lead which is why high impedance >10,000 is being seen.Since the new generators were shown to be working fine (per systems diagnostics ran with test resistors like 13, 22, 27) the issue appears to be with the lead and either an intermittent lead break or damaged caused to the lead.No additional relevant information has been received to date.While surgery is likely to correct the lead issue, it has not occurred to date.

Manufacturer Narrative

Describe event, corrected, data, initial mdr inadvertently omitted information that was relevant to sequence of events.

Event Description

After the new m104 was implanted, it was noted that the set screw had completely come out of the generator, which they were told this was ok, and to just screw it back in, until they hear the 2 clicks.They then stated that the septum plug had popped off while they were trying to screw the set screw back in which was likely user error.However, they could no longer use that generator.It was at this point that the second m104 used.

Manufacturer Narrative

Describe event or problem, corrected data, supplemental mdr #1 inadvertently omitted information that devices were received for analysis.

Event Description

Both m104 generators were received for analysis.Analysis i underway but has not been completed to date.

Event Description

Product analysis on the returned model 104 generators was completed and approved.The reported allegation of ¿detachment of component(s); septum plug¿, was not observed ¿as received¿ prior to decontamination.The header septum cavities both measured 0.127 (minus pin gauge set) inches (limits 0.125 inches +/-0.002).The header septum cavity meets specification requirements.A comprehensive automated electrical evaluation showed that the pulse generators performed according to functional specifications.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• 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: 7527070
• MDR Text Key: 108725213
• Report Number: 1644487-2018-00816
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/1995
• Device Model Number: 300-20
• Device Lot Number: ED-1141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/22/2018; 06/13/2018; 06/26/2018
• Supplement Dates FDA Received: 05/22/2018; 06/13/2018; 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/1993
• 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: 45 YR