LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH
Received Nov 2, 2015 · Event occurred Oct 8, 2015
Report 1627487-2015-07624 · MDR key 5196245
Device
Generic name
Scs Lead Devlivery System
Manufacturer
St. Jude Medical - NeuromodulationModel number
1772Lot number
5006851
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
(B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT¿S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT¿S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4).
Description of Event or Problem
IT WAS REPORTED THE PATIENT HAD A TRIAL PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING AFTER THE PHYSICIAN INSERTED EPIDURAL NEEDLE INTO THE PATIENT'S EPIDURAL SPACE. THE PATIENT HAD BEEN TAKING ASPIRIN WHICH MAY BE CONTRIBUTING TO THE BLEEDING. AS A RESULT, THE DOCTOR DECIDED TO ABANDON THE PROCEDURE.