FDA Adverse Event Injury Summary report: N

SOLYX SIS SYSTEM

MDR report key: 3182886 · Received June 21, 2013

Report

Report Number
3005099803-2013-05283
Event Type
Injury
Date Received
June 21, 2013
Date of Event
April 25, 2013
Report Date
May 29, 2013
Manufacturer
BOSTON SCIENTIFIC - MARLBOROUGH
Product Code
FTL
PMA / PMN Number
K081275
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED ON (B)(6) 2013. PHYSICIAN NOTES: DURING THE IMPLANTATION PROCEDURE, EXTREME FLEXION OF THE HIPS WAS NOTED AND THE PATIENT'S LEGS WERE REPOSITIONED TO EXTEND THE KNEES AND HIPS TO APPROXIMATELY 90 DEGREE ANGLES. ON THE DAY OF THE PROCEDURE, SHE COMPLAINED OF ACUTE LEFT INGUINAL PAIN RADIATING DOWN TO HER LEFT KNEE. THE PAIN WAS SHARP AND SOME THROBBING WAS NOTED. UPON STANDING SHE HAD SOME DIFFICULTY WITH WEIGHT BEARING. SHE WAS ABLE TO BEAR WEIGHT ON HER LEFT LEG, BUT WAS UNABLE TO MOVE HER LEFT LEG FORWARD WHILE STANDING. EXAMINATION REVEALED DECREASED SENSATION SHARP AND THE LEFT ANTERIOR THIGH. DECREASED PATELLAR TENDON REFLEXES WERE NOTED ON THE LEFT. DECREASED SHARP SENSATION NOTED ON THE LATERAL AS WELL AS THE RIGHT THIGH AND LOWER LEGS BILATERALLY. THE PATIENT WAS ADMITTED FOR OBSERVATION AND PAIN CONTROL. (B)(4) 2013, THE PATIENT HAD DECREASED PAIN AND WAS ABLE TO AMBULATE WITH A WALKER THOUGH SHE STILL HAD DIFFICULTY MOVING THE LEFT LEG FORWARD. EXAMINATION SHOWED EVIDENCE OF TENDERNESS IN THE MEDIAL THIGH. LEFT LEG ADDUCTION WAS REDUCED TO 1-2/4. ABDUCTION WAS REDUCED TO 3/4. PATELLAR TENDON REFLEXES WERE 4/4 BILATERALLY. IMPRESSION: LEFT OBTURATOR VS. FEMORAL NERVE INJURY; HER SYMPTOMS SEEMED TO BE MORE FOCAL FOR OBTURATOR RATHER THAN FEMORAL NERVE INJURY. PLAN: CONTINUE MEDROL AND PAIN MEDS. OBSERVE FOR LOCALIZATION OF SYMPTOMS TO OBTURATOR VS. FEMORAL DISTRIBUTION. IF PATIENT'S SYMPTOMS DID NOT IMPROVE SIGNIFICANTLY IN THE NEXT 48-72 HOURS, WOULD LIKELY RECOMMEND REMOVAL OF THE SUB-URETHRAL SLING WITH A PRESUMPTIVE DIAGNOSIS OF OBTURATOR NERVE IRRITATION. (B)(6) 2013: SYMPTOMS CONTINUED TO IMPROVE. A LEFT PUDENDAL NERVE BLOCK WITH LIDOCAINE 1% 10 ML & KENALOG 40 1 ML WAS PERFORMED AND RELIEVED HER PAIN SIGNIFICANTLY FOR SEVERAL HOURS. PAIN WAS CONTROLLED WITH P.O. MEDICATIONS. (B)(6) 2013: SYMPTOMS CONTINUED TO IMPROVE. SHE CONTINUED THE USE OF A WALKER, BUT WAS NOTED TO BE MUCH MORE MOBILE. SHE WAS NOW ABLE TO LIFT HER LEFT LEG ON A STAIR STEP. GABAPENTIN 100 MG T.I.D. WAS BEGUN. SHE WAS DISCHARGED HOME WITH A WALKER FOR AMBULATION, CONTINUING THE STEROID TAPER AND P.O. PAIN MEDS. (B)(6) 2013: PAIN WAS WELL-CONTROLLED WITH IBUPROFEN ONLY AND MOBILITY CONTINUED TO IMPROVE. SHE ONLY USED THE WALKER FOR REASSURANCE. (B)(6) 2013: OCCASIONAL NEED FOR WALKER. PAIN WITH SITTING, BUT MUCH LESS WITH STANDING OR LYING. PATIENT NOTED SIGNIFICANT IMPROVEMENT IN MOTOR FUNCTION. (B)(6) 2013: PATIENT HAD CONTINUING NERVE IRRITATION AND DISCOMFORT AND SLIGHTLY DECREASED MOTOR STRENGTH IN THE LEFT LOWER EXTREMITY. SHE WAS BEING TREATED WITH ANTI-INFLAMMATORY MEDICATIONS AND GABAPENTIN. HER DOSE OF GABAPENTIN WAS INCREASED THAT WEEK BY A NEUROLOGIST. SHE STILL COMPLAINED OF SIGNIFICANT PAIN WITH SITTING AND THAT HAD NOT CHANGED MUCH. RECEIVED A PUDENDAL NERVE BLOCK ON THIS DAY AND IT DID RELIEVE MUCH OF HER PAIN WITH SITTING. THE PHYSICIAN HOPED THE NERVE BLOCK WOULD AID HER RECOVERY REGARDING PAIN WITH SITTING. HE WANTED TO SEE HER AGAIN IN 10-14 DAYS FOR FOLLOW-UP AND WOULD CONSIDER 1-2 ADDITIONAL NERVE BLOCKS, AS PART OF THE BLOCK 10 ON THIS DAY WAS IN A FAIRLY NEW POSITION. ACCORDING TO THE PHYSICIAN, THE PATIENTS SYMPTOMS ARE CONSISTENT WITH OBTURATOR NERVE IRRITATION, WITH NO SPECIFIC NERVE DAMAGE IDENTIFIED. THE PATIENT HAD INCREASED PAIN AFTER HER LAST BLOCK, BUT PAIN HAS SINCE LEVELED OFF. ACCORDING TO THE PATIENT, HER LEFT LEG FEELS "CLUMSY". THE OPTIONS OF OBSERVATION VERSUS A REPEAT PUDENDAL NERVE BLOCK OR PARTIAL EXCISION OF THE LEFT SIDE OF THE SLING WERE DISCUSSED. FOLLOW-UP FROM PHYSICIAN ON (B)(6) 2013: THE PATIENT CONTINUES TO IMPROVE SLOWLY. HER SYMPTOMS ARE CONSISTENT WITH OBTURATOR NERVE IRRITATION. THAT IS, NO SPECIFIC NERVE DAMAGE WAS IDENTIFIED AT NEUROLOGY CONSULTATION AND FOLLOW-UP. THE PATIENT HAD INCREASED PAIN AFTER HER LAST BLOCK. PAIN IS NOW LEVELED OFF. SHE STILL FEEL LIKE HER LEFT LEG IS "CLUMSY". WE AGAIN DISCUSSED OPTIONS OF OBSERVATION VS. A REPEAT PUDENDAL NERVE BLOCK VS. PARTIAL EXCISION (OF THE LEFT SIDE OF THE SLING). SHE WILL FOLLOW UP NEXT WEEK TO DISCUSS FURTHER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
283965 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507001

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization