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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 Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 4591 lead, implanted: (b)(6) 2009. 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 Key7257648
MDR Text Key99905565
Report Number3004209178-2018-02842
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 02/08/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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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