MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	N051
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) previously showed three and a half years remaining longevity.During the recent check the device showed nine months left.Analysis showed that a low voltage fault was never declared and the device was depleting in a manner consistent with the low voltage capacitors advisory.There were no other suspicious faults or resets stored within device memory.The device hardware was not detecting the loss of battery energy.Because of this, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunctioning.The device should be replaced and returned for detailed analysis.As of this time, this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) previously showed three and a half years remaining longevity.During the recent check the device showed nine months left.Analysis showed that a low voltage fault was never declared and the device was depleting in a manner consistent with the low voltage capacitors advisory.There were no other suspicious faults or resets stored within device memory.The device hardware was not detecting the loss of battery energy.Because of this, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunctioning.The device should be replaced and returned for detailed analysis.This crt-d was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed.The battery voltage was lower than expected.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) previously showed three and a half years remaining longevity.During the recent check the device showed nine months left.Analysis showed that a low voltage fault was never declared and the device was depleting in a manner consistent with the low voltage capacitors advisory.There were no other suspicious faults or resets stored within device memory.The device hardware was not detecting the loss of battery energy.Because of this, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunctioning.The device should be replaced and returned for detailed analysis.This crt-d was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12735730
• Report Number: 2124215-2021-33353
• Device Sequence Number: 6859833
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/09/2015
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 101320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/03/2024; 10/24/2024
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 09/29/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female