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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 Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
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 setscrew of the attempted cardiac resynchronization therapy pacemaker (crt-p) was attached to the wrench while the doctor was trying to connect a lead to the device. A different device was used to complete the implant. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8241984
MDR Text Key132936295
Report Number3004209178-2019-00823
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2020
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2018
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

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