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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number REPLY DR
Device Problems Incomplete or Missing Packaging (2312); Noise, Audible (3273)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Event Description
Reportedly, during an incoming inspection, an abnormal sound was heard after a slight shaking of the orange carton box packaging of the subject pacemaker.An x-ray of the subject pacemaker carton box was performed, and compared with a control pacemaker carton box, and it was suspected that the foam inside the carton box of the subject pacemaker was missing.The device should be returned for analysis.Preliminary analysis results confirmed that the subject pacemaker was released according to all applicable procedures.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, during an incoming inspection, an abnormal sound was heard after a slight shaking of the orange carton box packaging of the subject pacemaker.An x-ray of the subject pacemaker carton box was performed, and compared with a control pacemaker carton box, and it was suspected that the foam inside the carton box of the subject pacemaker was missing.The device should be returned for analysis.Preliminary analysis results confirmed that the subject pacemaker was released according to all applicable procedures.
 
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Brand Name
REPLY
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n.
.
saluggia (vc), 13040
IT  13040
MDR Report Key11235167
MDR Text Key230545686
Report Number1000165971-2021-00241
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier08031527008899
UDI-Public(01)08031527008899(11)201112(17)220612
Combination Product (y/n)N
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/22/2021
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 Other
Device Expiration Date06/12/2022
Device Model NumberREPLY DR
Device Catalogue NumberREPLY DR
Device Lot NumberS0472
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/05/2021
Initial Date Manufacturer Received 01/05/2021
Initial Date FDA Received01/27/2021
Supplement Dates Manufacturer Received05/12/2021
Supplement Dates FDA Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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