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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR01
Device Problem Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 429888 lead, implanted: (b)(6) 2017. This device was reported as included in the field action. Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action. It is included in the field action in the abundance of caution. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the device had a divide by zero reset. The device was interrogated with a programmer containing the firmware update software. The device remains in use. It was also noted that several months prior there had been a lead impedance alert on both the left ventricular lead and the atrial lead for impedance out of range. Both leads remain in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The device was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated a software error. Analysis of the device memory indicated an issue with missing/invalid diagnostic data. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA QUAD CRTP
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7864456
MDR Text Key119824594
Report Number3004209178-2018-20335
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2413-2018

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-45 LEAD
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