Model Number 407652 |
Device Problems
Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/02/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during the implant procedure the lead helix would not retract.The lead was not used and a replacement lead was implanted.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the full lead was returned and analyzed.The analysis indicated that the helix of the lead was extrinsically bent.The helix of the lead became extrinsically distorted due to pulling/stretching/overstress.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|