MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1010

Device Problems Premature Discharge of Battery (1057); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

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

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that during a routine device interrogation the subcutaneous implantable cardioverter defibrillator (s-icd) displayed a code indicating there was a long charge time.It was further noted the s-icd was at elective replacement indicator (eri) battery status.Engineering review of the data stored in the device's memory found that most of the memory had been overwritten due to beeping from two months earlier.The cause of the tones was unable to be determined due to the overwritten memory.The long charge time code was determined not to be caused by charging f the high voltage capacitors.Engineering was ultimately unable to determine root cause as there were no capacitor charges stored in the device's memory.Replacement was recommended.Subsequently the s-icd was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Review of device memory found the device recorded a battery depletion alert along with elective replacement indicator (eri) and end of life (eol).It was noted the battery depletion alert occurred after explant.A long charge error was noted on may 18, 2019 and the s-icd started to beep 16 times a couple of times each day for the long charge error.During testing the s-icd was charged and a shock initiated.The shock pulse was short and found to be abnormal.The device case was removed to facilitate inspection of the internal components.Visual examination of the interior identified no anomalies.Detailed analysis identified an internal battery short that resulted in the observed depletion.The cause of the abnormal shock pulse found during analysis was determined to be due to the led cathode circuit which had an open connection in it.Note that the sq-rx (model 1010) s-icd is the only boston scientific device manufactured with a battery potentially susceptible to this particular issue.The sq-rx device is no longer manufactured; the current generation of s-icds contain a different battery (manufactured by boston scientific).This device was included in the november 2018 sq-rx model 1010 pg shortened replacement interval advisory population.

Event Description

This report is being filed to submit the analysis results.

• Brand Name: SQ-RX PULSE GENERATOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9209040
• MDR Text Key: 162859291
• Report Number: 2124215-2019-17576
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A013585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR