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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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MEDTRONIC, INC. MEDTRONIC CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number MDT-CRT-P
Device Problem Failure to Capture (1081)
Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Tachycardia (2095)
Event Date 10/18/2021
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is male/66 years old. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information was made. If additional information is obtained regarding this event, it will be added, and a supplemental report will be submitted accordingly. Referenced article: analyzing the impact of preoperative interrogation of cardiac implantable electronic devices. Annals of cardiac anaesthesia. 2021; 24:447-51. Doi: 10. 4103/aca. Aca_32_20. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding the impact of preoperative interrogation of cardiovascular implantable electronic devices (cied). The article reports patients who experienced perioperative cardiac events (intra- and postoperative) such as uncontrolled intraoperative atrial fibrillation (af) with rapid ventricular response (rvr), symptomatic sinus bradycardia with multiple inappropriate device shocks, loss of biventricular capture, symptomatic atrial tachycardia, new onset left bundle branch block, symptomatic bigeminy, torsades des pointes, symptomatic sinus tachycardia, and symptomatic premature ventricular contractions (pvc); these occurred with elective and emergent procedures. There were also cied related delays in surgeries. Patients with perioperative cardiac events were admitted to the intensive care unit (icu) for 24 hour observation and the devices were reassessed. The status/disposition of the devices and leads is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yield any additional information.
 
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Brand NameMEDTRONIC CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13052871
MDR Text Key282565147
Report Number2182208-2021-05018
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDT-CRT-P
Device Catalogue NumberMDT-CRT-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
Treatment
UNKNOWN LEADS
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