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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SERENA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR02
Device Problems Unable to Obtain Readings (1516); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during use of the cardiac resynchronization therapy pacemaker (crt-p), the device triggered an alert for left ventricular (lv) lead impedance out of range. A lv lead polarity switch was also observed, along with invalid data in the alerts log. It was noted the impedance measurement was incorrectly measured by the crt-p and the lead impedance measurements were within range. The crt-p remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA 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 Key9616770
MDR Text Key175912307
Report Number3004209178-2020-01562
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberW4TR02
Device Catalogue NumberW4TR02
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 Received12/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/13/2019
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: 01/22/2020 Patient Sequence Number: 1
Treatment
407652 LEAD, 407645 LEAD, 1458QL-75 LEAD
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