PRECISION®

Report

Report Number: 3006630150-2014-01669
Event Type: Injury
Date Received: July 23, 2014
Date of Event: May 29, 2014
Report Date: June 30, 2014
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT BELIEVE THAT THE STIMULATOR WAS THE CAUSE OF THE PATIENT¿S WORSENING OF PAIN AND THE COMPLAINT OF WEAKNESS WITH LOSS OF BALANCE.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT, WHO WAS NOTED TO HAVE LOST WEIGHT OVER THE LAST 6 MONTHS OR SO, NOW HAS HER IPG MORE PROTUBERANT TO THE SKIN. THE PATIENT FELT THAT THE PAIN HAD WORSENED AND THAT SHE HAD A NEW PAIN, MUSCLE JERKING. IT WAS ALSO REPORTED THAT THE PATIENT SUBJECTIVE WEAKNESS WITH LOSS OF BALANCE AT TIMES.