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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR01
Device Problems Failure to Capture (1081); High impedance (1291); Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure, the competitor guidewire was being removed from the left ventricular (lv) lead and became stuck. The wire was pulled and broke within the lead. The lead was tested and the pacing threshold was observed to be the same and the impedance had increased. It was decided to utilize the lead and once the lead was connected to the cardiac resynchronization therapy defibrillator (crt-d), the only pacing configuration that was available was lv1 to can and the bipolar impedance measurements were high. It was noted following the procedure, there was no capture observed. The pocket was re-opened and it was noted the lv pin was not fully inserted in the header of the crt-d. The lead was tested and found to be within limits. The lead was reconnected; the device and lv lead remain in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure, the competitor guidewire was being removed from the left ventricular (lv) lead and became stuck. The wire was pulled and broke within the lead. The lead was tested and the pacing threshold was observed to be the same and the impedance had increased. It was decided to utilize the lead and once the lead was connected to the cardiac resynchronization therapy pacemaker (crt-p), the only pacing configuration that was available was lv1 to can and the bipolar impedance measurements were high. It was noted following the procedure, there was no capture observed. The pocket was re-opened and it was noted the lv pin was not fully inserted in the header of the crt-p. The lead was tested and found to be within limits. The lead was reconnected;the device and lv lead remain in use. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9283038
MDR Text Key166978805
Report Number3004209178-2019-21108
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
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 Received11/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/30/2019
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: 11/05/2019 Patient Sequence Number: 1
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