PISCES-QUAD

Additional Manufacturer Narrative

CONTINUATION OF D10: PRODUCT ID 7427 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2000: PRODUCT TYPE IMPLANTABLE NEUROSTIMU LATOR MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT MENTIONED THEY NEEDED AN MRI OF THEIR HIPS BECAUSE THEIR HIPS WERE DETERIORATING AND THE PATIENT LOOKED LIKE THEY HAD TO HAVE HIP REPLACEMENT. PATIENT MENTIONED THEY HAD "DONE SEVERAL REVISIONS" PRIOR TO 2003. PATIENT SAID THEY HAD THEIR SPINAL CORD STIMULATOR REMOVED IN 2003, BUT WHEN THE SPINAL CORD STIMULATOR WAS REMOVED, A SECTION OF LEAD OR EXTENSION BROKE AND WAS LEFT IN THE PATIENT'S BODY. PATIENT DID NOT KNOW THE NAME OF THE HEALTHCARE PROVIDER WHO REMOVED THE DEVICE. AGENT REVIEWED MRI GUIDELINES WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.