Example 4: Manufacturer report : Injury

Nuvectra Corporation
BLAINE MN 55449
US
reporter occupation: HP HEALTH PROFESSIONAL

dates

Report Date: 2018-01-04
Event Date: 2017-12-06
Mfr Rec’d Date: 2017-12-08
FDA Rec’d Date: 2018-01-04
Date Added: 2018-01-04
Date Changed: 2018-01-04

device

  • product code: LGW
  • device name: Stimulator , Spinal-Cord, Totally Implanted For Pain Relief
  • brand: ALGOVITA SPINAL CORD STIMULATION
  • generic: STIMULATOR , SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
  • operator: 0HP HEALTH PROFESSIONAL
  • model #: 2412
  • catalog #: 2412
  • lot #:
  • other ID #:
  • evaluated by manufacturer: N
  • available: N
  • expires:
  • PMA/510K #:

description

IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED TO RE-POSITION THE STIMULATOR TO PROVIDE IMPROVED BATTERY RECHARGE. SUBSEQUENTLY, DURING SURGERY, THE STIMULATOR WAS REPLACED DUE TO BATTERY DRAINAGE. THE STIMULATOR BATTERY WAS NOT CHARGED PRIOR TO THE REVISION SURGERY. THE PATIENT IS DOING WELL.

other elements

  •  7165545
  •  3010309840-2017-00052
  •  Y
  •  Y
  •  N
  •  2018-01-04
  •  2017-12-06
  •  N
  •  Y
  •  2017-12-08
  •  2016-10-18
  •  Y
  •  N
  •  2018-01-04
  •  2018-01-04
  •  IN
  •  Injury
  •  M
  •  Manufacturer report
  •  0HP
  •  HEALTH PROFESSIONAL
  •  N
  •  No
  •  N
  •  No
  •  I
  •  Initial submission
  •  COMPANY REPRESENTATIVE
  •  COMPANY REPRESENTATIVE
  •  HEALTH
  •  HEALTH
  •  I
  •  Nuvectra Corporation
  •  NUVECTRA CORPORATION
  •  10675 NAPLES STREET NE
  •  BLAINE
  •  MN
  •  55449
  •  US
  •  55449
  •  IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED TO RE-POSITION THE STIMULATOR TO PROVIDE IMPROVED BATTERY RECHARGE. SUBSEQUENTLY, DURING SURGERY, THE STIMULATOR WAS REPLACED DUE TO BATTERY DRAINAGE. THE STIMULATOR BATTERY WAS NOT CHARGED PRIOR TO THE REVISION SURGERY. THE PATIENT IS DOING WELL.
  •  1.0
  •  2018-01-04
  •  ALGOVITA SPINAL CORD STIMULATION
  •  STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
  •  2412
  •  2412
  •  N
  •  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
  •  2018-01-04
  •  1. R