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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 09/30/2021
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the initial implant procedure for the cardiac resynchronization therapy pacemaker (crt-p) system, after the right ventricular (rv) lead was placed, the patient's pressures crashed. Cardiopulmonary resuscitation (cpr) was performed and the patient stabilized, an echocardiogram was done and no signs of effusion were noted. The physician continued with the procedure and placed the left ventricular (lv) lead. The patient then crashed and cpr was once again performed in addition to placing a balloon pump. The patient stabilized again, the device was placed in the pocket and it was noted that everything was functioning within normal limits. The patient then crashed a third time, additional attempts to resuscitate the patient failed and the patient died. It was noted prior to implant that the patient had a low ejection fraction and congestive heart failure but otherwise no injury. The patient's comorbidities and anesthesia were noted to be associated with the death during the procedure. It was also noted that another echocardiogram was done following the patient's death and still no signs of effusion were present and no device or lead performance issues were noted.
 
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Brand NamePERCEPTA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12701073
MDR Text Key278511674
Report Number9614453-2021-04093
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/08/2021
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: 10/26/2021 Patient Sequence Number: 1
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