SIGMA 300 D
Received Apr 11, 2014
Report 2647346-2014-00029 · MDR key 3743637
Device
Generic name
Pulse Generator, Permanent, Implantable
Manufacturer
Medtronic Puerto Rico Operations Co., HumacaoModel number
SD303Catalog number
SD303
Product problems
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE REVEALED LIFTED HYBRID BOND WIRES. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PHYSICIAN FOUND THE DEVICE CAN WAS DEFORMED AFTER THE DEVICE WAS REMOVED DURING A REPLACEMENT PROCEDURE. THE PHYSICIAN CONFIRMED THAT THERE WAS NO EXPLANT OVERSTRESS. THE PATIENT INDICATED THAT THERE WAS NO OVERSTRESS TO THE IMPLANTING AREA EITHER. THE PROGRAMMING PARAMETERS WERE ALL NORMAL BEFORE EXPLANTING. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.