• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR05
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 1156t ,lead, implanted: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the replacement procedure, the physician could not hear the clicking sound after connecting the lead to the cardiac resynchronization therapy pacemaker (crt-p).It was noted that the physician rotated the screwdriver many times and used another screwdriver, but no sound was heard.The lead measurements were good, and the fluoroscopy images showed the lead fit well in the connection port.The device remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SERENA CRT-P MRI SURESCAN
Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH  1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH   1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10017898
MDR Text Key189623544
Report Number9614453-2020-01392
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2020
Device Model NumberW1TR05
Device Catalogue NumberW1TR05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2020
Initial Date FDA Received05/01/2020
Supplement Dates Manufacturer Received05/01/2020
Supplement Dates FDA Received05/01/2020
Date Device Manufactured02/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
4092-58 LEAD, 4592-53 LEAD
Patient Age81 YR
-
-