Example 3: Voluntary report : Injury

Medtronic
reporter occupation: 305 PATIENT
MAUDE link: https://XXXXX

dates

Report Date: 2018-01-07
Event Date: 2017-04-13
Mfr Rec’d Date: 
FDA Rec’d Date: 2018-01-09
Date Added: 2018-01-10
Date Changed: 2018-01-11

device

  • product code: LGW
  • device name: Stimulator , Spinal-Cord, Totally Implanted For Pain Relief
  • brand: MEDTRONIC SPINAL CORD STIMULATOR
  • generic: MEDTRONIC SPINAL CORD STIMULATOR
  • operator: 0LP LAY USER/PATIENT
  • model #:
  • catalog #:
  • lot #:
  • other ID #:
  • evaluated by manufacturer: I
  • available: Y
  • expires:
  • PMA/510K #:

description

IMPLANTATION OF DEVICE CAUSED A SPREAD OF CRPS. HAD TO BE HOSPITALIZED. LATER NEEDED SURGERY TO CHANGE LOCATION OF BATTERY. LATER IN THE YEAR THE WIRES ALMOST CAME THROUGH MY SKIN REQUIRING ANOTHER SURGERY TO HAVE THEM PULL BACK IN FURTHER. TO THIS DAY THE WIRES GOING UP MY BACK CAUSE MODERATE PAIN 24/7. THIS IS WITH THE MEDTRONIC SPINAL CORD STIMULATOR . SPINAL CORD STIMULATOR IMPLANT DOESN’T WORK TO CONTROL PAIN LIKE THE TRIAL DID, NOT EVEN CLOSE.

other elements

  •  7178777
  •  MW5074481
  •  N
  •  Y
  •  N
  •  2018-01-07
  •  2017-04-13
  •  I
  •  *
  •  I
  •  N
  •  2018-01-10
  •  2018-01-11
  •  IN
  •  Injury
  •  P
  •  Voluntary report
  •  305
  •  PATIENT
  •  *
  •  No answer provided
  •  I
  •  NI
  •  NO INFORMATION
  •  Medtronic
  •  MEDTRONIC
  •  IMPLANTATION OF DEVICE CAUSED A SPREAD OF CRPS. HAD TO BE HOSPITALIZED. LATER NEEDED SURGERY TO CHANGE LOCATION OF BATTERY. LATER IN THE YEAR THE WIRES ALMOST CAME THROUGH MY SKIN REQUIRING ANOTHER SURGERY TO HAVE THEM PULL BACK IN FURTHER. TO THIS DAY THE WIRES GOING UP MY BACK CAUSE MODERATE PAIN 24/7. THIS IS WITH THE MEDTRONIC SPINAL CORD STIMULATOR. SPINAL CORD STIMULATOR IMPLANT DOESN’T WORK TO CONTROL PAIN LIKE THE TRIAL DID, NOT EVEN CLOSE.
  •  1.0
  •  2018-01-09
  •  MEDTRONIC SPINAL CORD STIMULATOR
  •  MEDTRONIC SPINAL CORD STIMULATOR
  •  Y
  •  I
  •  0LP
  •  LAY USER/PATIENT
  •  LGW
  •  Stimulator , Spinal-Cord, Totally Implanted For Pain Relief
  •  NE
  •  Neurology
  •  3
  •  Devices subject to General Controls, Special Controls, and Premarket Clearance
  •  N
  •  Not Eligible for Accredited Persons Program
  •  2
  •  PMA
  •  1
  •  2018-01-09
  •  1. H; 2. S