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Catalog Number UNKNOWN POWER PORT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arrhythmia (1721)
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Event Date 04/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events is unknown.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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Event Description
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The following adverse events were identified in several studies utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bard¿ long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the arrhythmia reported during the use of the power port m.R.I.Implantable port product (unknown product code).Events range in dates from june 17, 2017-may 11, 2022.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding these events is available.
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Event Description
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The following adverse events were identified in several studies utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bard¿ long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the arrhythmia reported during the use of the power port m.R.I.Implantable port product (unknown product code).Events range in dates from june 17, 2017-may 11, 2022.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding these events is available.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, the clinical event alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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