Model Number 6788 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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It was reported that the patients ipg would not communicate with external devices and confirmed to be inoperable.As a result, surgical intervention may be pending at a later date to address the issue.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received identified that patient underwent surgical intervention wherein, the ipg was explanted and replaced.Effective therapy was restored post operatively.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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"a depleted ipg was reported to abbott.As a result, the ipg was explanted and replaced.Therapy was restored.The device was not returned for disposal/evaluation.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, a single definitive root cause for the reported issue was unable to be conclusively determined.".
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Search Alerts/Recalls
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