FDA.reportPublic FDA data

MAUDE MDR 2751232

MDR report key
2751232
Report number
2210968-2012-05458
Event key
0
Event type
3
Date received
2012-09-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL LAMONT
Address
ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHIBOND EXTRA & EXCEL POLYESTER SUTURESUTURE, NON-ABSORBABLEETHICON, INC.GASNAMX833DBM197Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-1901. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL CORD STIMULATOR IMPLANT PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED TO ANCHOR THE LEAD. THE LEAD WAS MIGRATING AND THE SURGEON DISCOVERED THAT THE NON-ABSORBABLE SUTURE HAD ABSORBED. THERE WAS NO REMNANT OF SUTURE LEFT AT THE ANCHOR. A DIFFERENT TYPE OF SUTURE WAS USED IN A FOLLOW-UP SURGERY TO CORRECT THE PROBLEM. ADDITIONAL INFORMATION WAS REQUESTED.

N

Patient 1

(B)(4). SUTURE ABSORBED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

N

Patient 1

CONCLUSION: ONE REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. NO ACTUAL RETURNED USED SUTURE OR EXPLANTS WERE PROVIDED, SO A COMPLETE EXAMINATION WAS NOT POSSIBLE. IT COULD NOT BE DETERMINED WHAT SUTURE WAS ACTUALLY USED IN THE PROCEDURE .