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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 5076-85
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Complete Heart Block (2627)
Date of Event 01/02/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the full lead was returned.Analysis was performed and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient was experiencing occasional complete heart block.An x-ray verified both the right atrial (ra) and right ventricular (rv) leads had dislodged.Both leads were explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7417089
Report Number2649622-2018-04629
Device Sequence Number1637459
Product Code DTB
UDI-Device Identifier00643169550797
UDI-Public00643169550797
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date01/26/2019
Device Model Number5076-85
Device Catalogue Number5076-85
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2018
Initial Report FDA Received Date04/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age66 YR
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