Model Number 3116 |
Device Problems
Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/31/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.
|
|
Event Description
|
The manufacturer representative reported that the patient had an expired implantable neurostimulator (ins) and 1 expired lead implanted.The ins and leads were implanted on (b)(6) 2016, but the ins had reached its use by date (ubd) on (b)(6) 2016 and the lead had reached its ubd on (b)(6) 2015.The indication for use for this patient was gastrointestinal/pelvic floor.
|
|
Manufacturer Narrative
|
Device code no longer applies to the event.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.
|
|
Event Description
|
Additional information received from the health care provider (hcp) reported that the correct implant date was (b)(6) 2014 for the ins and lead.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|