MAUDE Adverse Event Report: BOSTON SCIENTIC CORPORATION CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number G247

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Chest Pain (1776); Shock from Patient Lead(s) (3162); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Pain from spasms in chest; horrific spasms in chest.Doubled me over and at times could not breath.Had ekg at (b)(6).Dr (b)(6).He and tech stopped pacemaker.Did nothing with defibrillator.Reduced pacing or defibrillator to "50?" (b)(6) while sleeping defibrillator i believe got an incorrect reading and while sleeping shocked me.I take metropol and heart rate never high.Have no arrhythmias.About first week of (b)(6) horrific spasms started occurring.Dr said not heart.Yesterday, (b)(6) 2021 dr (b)(6) did not listen to my heart nor did i get results from ekg.I am having it emailed.Fda safety report id # (b)(4).

• Brand Name: CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): BOSTON SCIENTIC CORPORATION
• MDR Report Key: 12804295
• MDR Text Key: 280880772
• Report Number: MW5105284
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/09/2021

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 Model Number: G247
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 40 MG; AZALESTINE NASAL SPRAY; BUMETANIDE 2 MG 2 TIMES DAILY ; FIBER GUMMIES ; GLIMPERIDE 1 MG; KLONOPIN ; LEVOTHYROXINE 50 MCG ; LYRICA; METFORMIN .500 MG; METOPROLOL TARTRATE 50 MG; MULTI VITAMIN ; MUSCLE RELAXER ; NITRO .04 MG; OMNIPROSOL ; PLAVIX 75 MG; RANEXA 1000 MG; STOOL SOFTENER ; SUPER COMPLEX ; TAMSULOSIN 0.4 MG; VITAMIN B ; VITAMIN C. ; VITAMIN D ; VITAMINS E
• Patient Outcome(s): Required Intervention; Life Threatening; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White