BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
|
Back to Search Results |
|
Model Number SC-2218-50 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Impaired Healing (2378)
|
Event Date 12/04/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event: exact date unknown, event occurred after the implant procedure date of (b)(6) 2020.Additional suspect medical device component involved in the event: product family: scs-linear leads: upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 7082751.
|
|
Event Description
|
It was reported that the patient's midline incision had delayed healing and redness was noted at the wound site.The midline incision was open at the top with no edema, drainage, or tunneling observed.The patient was referred to wound care.
|
|
Event Description
|
It was reported that the patients midline incision had delayed healing and redness was noted at the wound site.The midline incision was open at the top with no edema, drainage, or tunneling observed.The patient was referred to wound care.Additional information was received that the patient was placed on antibiotics.
|
|
Search Alerts/Recalls
|
|
|