Model Number 3387S-40 |
Device Problems
Bent (1059); Shipping Damage or Problem (1570)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/29/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a manufacturing representative (rep) regarding an event with no patient involvement.It was reported that the lead tip was bent when it came out of the packaging.The lead was not used.No further complications were reported as a result of this event.
|
|
Manufacturer Narrative
|
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
No additional information was received.
|
|
Manufacturer Narrative
|
Analysis of the lead (lot# va1jsax) revealed that the distal end of the lead was bent at the #0 electrode.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code 12 because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.Product analysis #:(b)(4).Analysis information -- (b)(6) 2017.22:17:39 cst pli# 10 product id# 3387s-40 below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis confirmed that the distal end of the lead was bent.{electrical testing of the lead determined that continuity was comple te and no electrical shorts were observed between circuits.} electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.{the distal end of the lead is bent at the #0 electrode.} if information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|