FDA.reportPublic FDA data

MAUDE MDR 7757

MDR report key
7757
Report number
7757
Event key
0
Event type
3
Date of event
1993-06-29
Date received
1994-02-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPINAL EPIDURAL STIMULATORMEDTRONICSGZD7424YY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-02-0401. O

Event Narratives#

D

Patient 1

SPINAL EPIDURAL STIMULATOR IMPLANTED ON APRIL 27, 1993, FOR CHRONIC RADICULAR LEG PAIN. THE STIMULATOR AT THIS TIME IS NO LONGER FUNCTIONING WELL, AND INTERMITTENTLY SHOCKS HER. RE-ADMITTED ON JUNE 29, 1993, FOR REVISION OF THE SPINAL EPIDURAL STIMULATOR.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.