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

Model Number	V172
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)
Date of Event	01/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This device was not returned as our records indicate it was retained by the explanting hospital.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 pacemaker (crt-p) had entered safety mode, and the associated codes were 0x40, 0x0, 0x0.The patient presented to the emergency room (er) due to syncope.Additional information received indicated that this crt-p exhibited oversensing and pacing inhibition with greater than two seconds of asystole.This crt-p was explanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode, and the associated codes were 0x40, 0x0, 0x0.The patient presented to the emergency room (er) due to syncope.Additional information received indicated that this crt-p exhibited oversensing and pacing inhibition with greater than two seconds of asystole.This crt-p was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was not returned as our records indicate it was retained by the explanting hospital.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVIVE
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11234100
• Report Number: 2124215-2021-02323
• Device Sequence Number: 3859681
• Product Code: NKE
• UDI-Device Identifier: 00802526536625
• UDI-Public: 00802526536625
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/18/2014
• Device Model Number: V172
• Device Catalogue Number: V172
• Device Lot Number: 100620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR