FDA Adverse Event Other Summary report: N

MEDTRONIC SPINAL CORD STIMULATOR (NOT IN PROTOCOL)

MDR report key: 1488115 · Received September 16, 2009

Report

Report Number
MW5012863
Event Type
Other
Date Received
September 16, 2009
Date of Event
July 21, 2009
Product Code
LGW
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2009, THE SUBJECT'S LAB RESULTS INCLUDED CPK OF 1452 (RANGE 18-198), CREATINE KI-NASE/MYOCARDIAL BANDS (CK-MB) 20.2 (RANGE 0.7-4.9) AND CK-MB RAI 1.4 (RANGE 0.1-2.5). BASELINE CPK WAS NOTED TO BE 199 U/L ABOUT 2 MONTHS PRIOR. THE SUBJECT REPORTED THAT HE HAD SPENT THE WEEKEND (3 DAYS) MOVING INTO A NEW HOUSE; HE HIRED MOVERS AND DID NOT LIFT HEAVY BOXES OR FURNITURE. FURTHER, HE DENIED FALLS OR TRAUMA. HE HAD ALSO NOTED A THREE-POUND WEIGHT GAIN SINCE HIS LAST VISIT. HE WAS ASYMPTOMATIC, NOT HOSPITALIZED AND DID NOT REQUIRE TREATMENT. LAB VALUES ABOUT 9 DAYS LATER INCLUDED CPK OF 451 U/L, QUANTITATIVE TROPONIN-I <0.03 NG/ML, LACTATE DEHYDROGENASE (LD) 192 U/L AND BRAIN NATRIURETIC PEPTIDE 13.4 PG/ML. AN ELECTROCARDIOGRAM (EKG) ABOUT 9 DAYS LATER WAS NORMAL. LAB VALUES AT ABOUT ONE WEEK LATER INCLUDED CPK OF 222 U/L. THE SUBJECT WAS REFERRED BY HIS PRIMARY CARE PHYSICIAN TO A CARDIOLOGIST DUE TO HIS ELEVATED CPK LEVEL (222). THE CARDIOLOGIST'S IMPRESSION ABOUT 2 WEEKS LATER INCLUDED NON-SPECIFIC CPK ELEVATION; APPEARED AS THOUGH THE SUBJECT MAY HAVE HAD EARLY POSTURAL HYPERTENSION AND A STRESS TEST WAS NOT JUSTIFIED. THE EKG WHILE IN THE OFFICE WAS NORMAL AND HE WAS INSTRUCTED TO TAKE HIS TIME GETTING OUT OF CHAIRS AND STAY WELL HYDRATED. THE CARDIOLOGIST EXPLAINED TO THE SUBJECT THAT AN ELEVATED CPK WAS ENTIRELY NONSPECIFIC AND IT COULD HAVE SOME RELATIONSHIP TO THE MEDTRONIC SPINAL STIMULATOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC SPINAL CORD STIMULATOR (NOT IN PROTOCOL) NONE LGW UNK

Patients

Seq Age Sex Outcome Treatment
1 47 YR