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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number 4513
Device Problem Pocket Stimulation (1463)
Patient Problems Muscle Stimulation (1412); No Code Available (3191)
Event Date 10/05/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event Description
It was reported that the patient with this left ventricular (lv) lead experienced diaphragmatic stimulation and due to lead being unipolar, lead could not be reprogrammed.Hence, this lv lead was surgically abandoned.No additional adverse patient effects were reported.
 
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Brand Name
NA
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
CPI - DEL CARIBE
guidant puerto rico b. v.
#12, rd. #698
dorado PR 00646
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key11040349
MDR Text Key222630994
Report Number2124215-2020-25056
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/29/2005
Device Model Number4513
Device Catalogue Number4513
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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