ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Sep 19, 2012
Report 2210968-2012-05459 · MDR key 2751214
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
MX833
Lot number
DBM197
Product problems
- Absorption
Patient
Not reported
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
DATE SENT TO THE FDA: (B)(4) 2012. PATIENT (B)(4) - SUTURE ABSORBED. (B)(4). 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.
Additional Manufacturer Narrative
(B)(4). 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 .
Remedial action
- Other