MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD VR; IMPLANTABLE DEVICE

Model Number D150

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/05/2018

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) had triggered a code 1003 indicative of battery voltage too low for projected remaining capacity and a code 1007 due to capacitor charge time exceeding the limit.Data analysis showed the battery appeared to be depleting more quickly then expected.Device replacement was recommended.Subsequently, this patient underwent a replacement procedure and this product was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert code 1003 was recorded, potentially indicative of early battery depletion.Analysis confirmed partial depletion; brady therapy was available however, tachy therapy was not.The early depletion was caused by electrical leakage of a low voltage capacitor in the presence of excess hydrogen gas within the pulse generator case.

Event Description

This supplemental is being filed to include device analysis information.

• Brand Name: DYNAGEN EL ICD VR
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9550662
• MDR Text Key: 173682639
• Report Number: 2124215-2020-00007
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: 00802526534287
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: 05/20/2017
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 193683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR