FDA Adverse Event Other Summary report: N

MEDX

MDR report key: 230935 · Received July 7, 1999

Report

Report Number
MW1016705
Event Type
Other
Date Received
July 7, 1999
Date of Event
May 22, 1999
Report Date
July 7, 1999
Manufacturer
MEDX 96, INC.
Product Code
ION
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
UT, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DR. WAS CONTACTED TO GIVE HIS OPINION REGARDING THE PT'S HORMONE LEVELS, AS TO WHETHER OR NOT THEY WERE SUFFICIENT. THE REPORTER SOUGHT THE DR'S OPINIONBECAUSE HE IS AN EMBRYOLOGIST AND THE FACT THAT FOR EIGHT YEARS THE DR WAS THE PROGRAM DIRECTOR FOR ONE OF THE MOST SUCCESSFUL IN-VITRO FERTILIZATION PROGRAMS IN THE NATION. ALTHOUGH NOT A PHYSICIAN, BUT A PH.D EMBRYOLOGIST, WHILE AT THIS PROGRAM, THE PHYSICIANS WOULD SEEK HIS OPINION ON IMPLANTATION OF EMBRYOS AND LUTEAL PHASE INFLUENCES OF THE HORMONES. THE LUTEAL PHASE INFLUENCES NOT ONLY THE PREPARATION OF THE UTERUS FOR IMPLANTATION OF AN EMBRYO BUT ALSO MAINTENANCE OF THE PREGNANCY THROUGH ITS FIRST 10-12 WEEKS. THE REPORTER DID BLOOD TESTS ON HIS WIFE ON 4/21/199, TO LOOK AT THE ESTRADIOL AND PROGESTERONE LEVELS. IF THESE TESTSHAD SHOWN A LOW LEVEL, SHE WOULD HAVE HAD WHAT IS CALLED A LUTEAL PHASE DEFECT, WHICH CAN BE EASILY TREATED. THE BLOOD TESTS ON 4/21/99 SHOWED THE PT TO HAVE AN ESTRADIOL LEVEL AND PROGESTERONE LEVEL BOTH WELL WITHIN NORMAL RANGES. HOWEVER, SHE WAS STILL PUT ON SUPPLEMENTAL PROGESTERONE AND ESTROGEN FOR INSURANCE MEASURES AS THE SUPPLEMENTAL HORMONES WOULD PROTECT THE EMBRYO IN THE EVENT THAT THE PRODUCTION OF PROGESTERONE AND/OR ESTRADIOL FROM THE CORPUS LUTEUM WAS NOT GREAT ENOUGH TO STIMULATE APPROPRIATE ENDOMETRIAL GROWTH AND DEVELOPMENT. THE CONSTANT MONITORING OF THESE HORMONES ALWAYS SHOWED TO BE SUFFICIENT AND THE FINAL BLOOD TEST OF 5/25/99 SHOWED BOTH LEVELS TO BE WELL WITHIN NORMAL RANGES. THESE LEVELS INDICATE THAT THE PT'S MISCARRIAGE WAS PROBABLY NOT DUE TO HORMONAL ABNORMALITIES WHICH WOULD PRODUCE DEFICIENCIES WITHIN THE ENDOMETRIAL TISSUE OR WHAT IS COMMONLY CALLED A LUTEAL PHASE DEFECT. CERTIFIED NURSE MIDWIFE WRITES: THE PT WAS RECEIVING CARE FROM "ME FOR HER PREGNANCY IN APRIL AND MAY OF THIS YEAR. SHE RECEIVED CARE FROM ME DURING HER LAST PREGNANCY THREE YEARS AGO. AT THAT TIME SHE SUFFERRED SEVERE LOW BACK PAIN AND COULD NOT AMBULATE WITHOUT CRUTCHES. IN AN ATTEMPT TO PROVIDE PREVENTIVE CARE THIS PREGNANCY, I CONTACTED THE SPINAL TREATMENT AND REHAB CENTER AND ASKED TO SPEAK WITH A PHYSICAL THERAPIST WHO DEALT WITH MEDX. MY UNDERSTANDING OF THE MEDX MACHINE WAS THAT IT PROVIDED A COMPUTERIZED DIAGNOSIS OF LOW BACK PAIN AND WOULD THEREFORE ALLOW FOR THE CREATION OF A MUSCLE STRENGTHENING PROGRAM."CNM SPOKE WITH THE PRACTITIONER AT THE CENTER AND EXPLAINED THE PT'S CONDITION. CNM ASKED IF THE DEVICE HAD BEEN USED IN THE PAST IN PREGNANCY AND HE COULD NOT GIVE A DEFINITIVE ANSWER. CNM TOLD HIM THAT SHE WOULD SEND THE PT OVER FOR CONSULTATION AND TREATMENT OF LOW BACK PAIN AND THAT THE TWO OF THEM COULD DECIDE AN APPROPRIATE TREATMENT PLAN. CNM WAS NEVER INFORMED THAT THE PRACTITIONER WAS NOT A PHYSICAL THERAPIST. CNM WAS NEVER INFORMED THAT THE PRACTITIONER CONSULTED A PHYSICAL THERAPIST AND WAS TOLD THAT THE MEDX WAS CONTRAINDICATED IN PREGNANCY. AT THE TIME CNM WAS FOLLOWING PT FOR THIS PREGNANCY SHE HAD NO INDICATIONTHAT SHE WAS HAVING ANY PROBLEMS WITH HER PREGNANCY THAT WOULD LEAD HER TO SUSPECT THAT SHE WOULD MISCARRY. SHE DID HAVE A NORMAL ULTRASOUND WITH A VIABLE PREGNANCY ON MAY 18, 1999. CNM SUPPORTS THE PT IN HER EFFORTS TO HAVE BETTER LABELING AND INFORMED CONSENT PRIOR TO THE USE OF MEDX.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDX MEDX LUMBAR ION MEDX 96, INC. LU 53 *

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other