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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5076-52
Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
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 the implant attempt the right atrial (ra) lead the screw appeared to be out already.The physician attempt to retract the screw with no success.The lead was not implanted, and a different lead was used.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.
 
Event Description
It was reported that during the implant attempt the right atrial (ra) lead the screw appeared to be out already.The physician attempt to retract the screw with no success.The lead was not implanted, and a different lead was used.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis indicated that the distal conductor of the lead was extrinsically over-rotated.Visual analysis of the lead indicated damage at implant.The analyst noted that the lead was received with the helix fully retracted, and distortion of the distal conductor within the is-1 connector.This is indicative of the connector pin being turned an excessive number of times during helix retraction.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 Name
CAPSUREFIX NOVUS
Type of Device
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7747651
MDR Text Key116151331
Report Number2649622-2018-12718
Device Sequence Number0
Product Code DTB
Reporter Country CodeUS
PMA/PMN Number
P930039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/17/2020
Device Model Number5076-52
Device Catalogue Number5076-52
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age73 YR
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