Example 2: Manufacturer report : Malfunction

Medtronic

MEDTRONIC NEUROMODULATION

MINNEAPOLIS MN 55421 1200
US

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

dates

Report Date: 2018-01-19
Event Date: 
Mfr Rec’d Date: 2018-01-17
FDA Rec’d Date: 2018-01-19
Date Added: 2018-01-19
Date Changed: 2018-01-19

device

  • product code: LGW
  • device name: Stimulator , Spinal-Cord, Totally Implanted For Pain Relief
  • brand:
  • 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 PROSPECTIVE PATIENT REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS THE INS AND THE IMPLANT DID NOT WORK FOR HER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

other elements

  •  7206038
  •  3007566237-2018-00206
  •  Y
  •  N
  •  Y
  •  2018-01-19
  •  N
  •  I
  •  2018-01-17
  •  Y
  •  I
  •  2018-01-19
  •  2018-01-19
  •  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 PROSPECTIVE PATIENT REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS THE INS AND THE IMPLANT DID NOT WORK FOR HER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.
  •  1.0
  •  2018-01-19
  •  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
  •  2018-01-19