Example 1: Manufacturer report : Malfunction

 Medtronic
MEDTRONIC NEUROMODULATION

MINNEAPOLIS MN 55421 1200
US

reporter occupation: OTHER
MAUDE link: https://XXXXX

dates

Report Date: 2018-01-23
Event Date: 
Mfr Rec’d Date: 2018-01-19
FDA Rec’d Date: 2018-01-23
Date Added: 2018-01-23
Date Changed: 2018-01-23

device

  • product code: LGW
  • device name: Stimulator , Spinal-Cord, Totally Implanted For Pain Relief
  • brand: IMPLANTABLE NEUROSTIMULATOR
  • generic: STIMULATOR , SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  • operator: 0HP HEALTH PROFESSIONAL
  • model #: NEU_INS_ STIMULATOR
  • catalog #: NEU_INS_ STIMULATOR
  • lot #:
  • other ID #:
  • evaluated by manufacturer: *
  • available: N
  • expires:
  • PMA/510K #:

description

INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HOPED ANOTHER PRODUCT WORKED BETTER THAN THE MANUFACTURER’S SPINALSTIMULATORS BECAUSE THE PATIENT HAD FOUR IN 18 MONTHS AND IT DESTROYED THEIR SPINE.

other elements

  •  7213450
  •  3007566237-2018-00239
  •  Y
  •  Y
  •  Y
  •  2018-01-23
  •  N
  •  N
  •  2018-01-19
  •  Y
  •  I
  •  2018-01-23
  •  2018-01-23
  •  M
  •  Malfunction
  •  M
  •  Manufacturer report
  •  000
  •  OTHER
  •  U
  •  Unknown
  •  *
  •  No answer provided
  •  I
  •  Initial submission
  •  CONSUMER
  •  CONSUMER
  •  I
  •  Medtronic
  •  MEDTRONIC NEUROMODULATION
  •  800 53RD AVE NE
  •  MINNEAPOLIS
  •  MN
  •  55421
  •  1200
  •  US
  •  554211200
  •  IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
  •  INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HOPED ANOTHER PRODUCT WORKED BETTER THAN THE MANUFACTURER’S SPINAL STIMULATORS BECAUSE THE PATIENT HAD FOUR IN 18 MONTHS AND IT DESTROYED THEIR SPINE.
  •  1.0
  •  2018-01-23
  •  IMPLANTABLE NEUROSTIMULATOR
  •  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  •  NEU_INS_STIMULATOR
  •  NEU_INS_STIMULATOR
  •  N
  •  *
  •  0HP
  •  HEALTH PROFESSIONAL
  •  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
  •  2018-01-23