Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Delayed Charge Time (2586); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2013 |
Event Type
Injury
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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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Caller reports coupling and or communication issues.An ins over discharge is suspected.The last successful recharging session was l ess than 1 month ago.Two weeks ago.Pt stating that he has been able to get any communication with ins.Hcp states he can't get communication with 8840.Hcp stated that they charged for an hour with about 6 coupling bars but haven't seen the ins battery increase.Hcp checked it with 8840 and it states battery is discharged.Hcp states this has happened once before because pt is dystonia pt and runs at 5.0v and 6.0v for both sides.Reviewed how to reposition antenna and press start charge button.Reviewed how to adjust antenna dial.Reviewed recharge statistics to check if ins is taking on a charge.Insr showed that pt for the most recent charging session: 0: 01/30/13, 6 min, start voltage: 3.390, end voltage: 3.470.Reviewed with hcp the insr is showing correct battery level and that they need to spend more time recharging.Reviewed more coupling bars and maintaining them allow for quicker recharging times.Attempted to charge again and they were only get 2 bars, instructed to adjust antenna dial and they got 8 bars also by positioning patient in laying position.They were going to continue to charge and get battery up to 25% and then recheck battery.No por were seen.Additional information was received from a consumer indicating the device was replaced after depleting three different times.
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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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Additional information received from a consumer indicated they had gotten the replacement part and it was working great.
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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.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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Search Alerts/Recalls
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