MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Premature Discharge of Battery (1057); Pocket Stimulation (1463)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

The returned cardiac resynchronization therapy pacemaker (crt-p) was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) experienced hiccups and double vision.Boston scientific technical services (ts) discussed that the hiccups could be due to nerve or muscle stimulation.Thus, recommended contacting clinic and seeking medical attention as appropriate.Additional information obtained from the field which indicated that the device was explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12620382
• MDR Text Key: 276202343
• Report Number: 2124215-2021-26810
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

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: 12/21/2013
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 100088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 96 YR