MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Premature Discharge of Battery (1057); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2020

Event Type  malfunction  

Event Description

It was reported that a connection could not be established with a packaged m103 generator.It was reported that multiple different programming systems were attempted to be used but were unable to communicate with the generator.A review of device history records revealed that the generator passed all functional specifications and quality tests prior to distribution.The generator has not been received by the manufacturer for product analysis to date.No further relevant information has been received to date.

Event Description

The suspect device, generator, was received by the manufacturer but has not been evaluated by product analysis to date.No other relevant information has been received to date.

Event Description

The suspect device underwent product analysis.The failure to program due to a suspected generator issue was duplicated in the product analysis lab.Once the generator case was removed, the battery measured 0.481 volts indicating an end of service (eos) condition.A visual assessment on the printed circuit board assembly (pcba) showed what appears to be solder bridge across pins 47 and 48 of the microprocessor a1.Suspect that the solder bridge between the pins 47 and 48 of the microprocessor a1 inadvertently produced an increase in the supply current off-time current that caused the battery to swell and the asic (a2) to malfunction resulting in the reported allegations of failure to program and suspected generator issue.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10496817
• MDR Text Key: 208114470
• Report Number: 1644487-2020-01169
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

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: Other
• Device Expiration Date: 10/09/2020
• Device Model Number: 103
• Device Lot Number: 204702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Event Location: Other
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 10/15/2020
• Supplement Dates FDA Received: 10/02/2020; 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1