MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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Model Number D314VRG |
Device Problems
Premature Discharge of Battery (1057); Delayed Charge Time (2586); Protective Measures Problem (3015)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardioverter defibrillator (icd) alerted for an excessive charge time and declared end of service (eos) with a battery voltage that had not reached recommended replacement time (rrt) yet.The battery longevity was less than expected.The device remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis revealed that the device analysis confirmed that the device did not charge efficiently with the original device battery.The device charged nominally when the battery was replaced with an external supply.No hybrid anomalies were found.Battery analysis revealed that no evidence of internal shorting was found during destructive analysis.Lithium severing was seen on anode segment 8.Scalloping and partial severing was observed on anode segments 3, 5, and 6.The charge timeout was likely due to increased battery resistance induced by observed lithium-severing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the device was removed and a new device was implanted.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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