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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SERENA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR02
Device Problem Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: 4591 lead, implanted: (b)(6) 2009. Product event summary: the device was returned and analyzed and no anomalies were found. The device had foreign material in the connector. The device had a damaged connector and grommet. The set screw was found in the connector bore. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that multiple lead insertion attempts into the left ventricular port of the attempted cardiac resynchronization therapy pacemaker (crt-p) had failed. The lead would not advance. The doctor backed out the setscrew further and tried again with the same result. A new crt-p was then utilized with complete lead insertion; however, undefined lead impedance was observed and several insertions were necessary before impedance measured within normal limits. The second device remains in use. The physician was concerned about the mechanism in the crt-ps to secure electrical conduction. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA 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 Key7257601
MDR Text Key106698945
Report Number3004209178-2018-02841
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,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
Device Model NumberW1TR02
Device Catalogue NumberW1TR02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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