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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PAMIRA S 65; ICD LEAD
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BIOTRONIK SE & CO. KG PAMIRA S 65; ICD LEAD Back to Search Results
Model Number 428769
Device Problem High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
Threshold increase (1.5 v to 4.0 v) was noted one day after implantation.A repositioning procedure was attempted.The screw could be retracted but could not be fully extended, so a new lead was used.
 
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
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Brand Name
PAMIRA S 65
Type of Device
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
DE  12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key19000327
MDR Text Key338924478
Report Number1028232-2024-01759
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
P980023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number428769
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Date Device Manufactured01/29/2024
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 Outcome(s) Hospitalization;
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