Example 5: Manufacturer report : Malfunction

Medtronic

MEDTRONIC NEUROMODULATION

MINNEAPOLIS MN 55421 1200
US

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

dates

Report Date: 2018-01-05
Event Date: 
Mfr Rec’d Date: 2017-12-30
FDA Rec’d Date: 2018-01-02
Date Added: 2018-01-02
Date Changed: 2018-01-05

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

CONCOMITANT PRODUCT(S): PRODUCT ID: NEU_INS_ STIMULATOR , LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

other elements

  •  7157376
  •  3007566237-2018-00020
  •  Y
  •  Y
  •  Y
  •  2018-01-05
  •  N
  •  N
  •  2017-12-30
  •  Y
  •  I
  •  2018-01-02
  •  2018-01-05
  •  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
  •  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT THAT WAS IMPLANTED WITH TWO IMPLANTABLE NEUROSTIMULATORS (INS). IT WAS REPORTED THAT ONE INS WAS PUT IN 2010 AND THE OTHER IN 2011. BOTH INSS HAVE BEEN DEAD FOR OVER TWO YEARS, AND NOT ON IN OVER TWO YEARS. IT WAS NOTED THAT THE PATIENT USED THE INSS IN THE FIRST TWO YEARS AND WAS GREAT. NOW THE PATIENT WAS BEING SHOCKED OR ELECTROCUTED FROM THE INSIDE OUT. �THIS WAS CRAZY� AND �JUST WRONG�. THE PATIENT WAS GOING TO BE GOING TO THE ER TONIGHT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
  •  CONCOMITANT PRODUCT(S): PRODUCT ID: NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
  •  1.0
  •  2018-01-02
  •  IMPLANTABLE NEUROSTIMULATOR
  •  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  •  NEU_INS_STIMULATOR
  •  NEU_INS_STIMULATOR
  •  N
  •  DA
  •  *
  •  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
  •  2018-01-02