ANALYSIS OF MAUDE FDA REPORTS FOR NEVRO RECEIVED 1/12/18-2/28/18 (Dates are date of event, not reported date)- ANALYSIS OF The LAST 100 REPORTS RECEIVED (out of the 486 received)
46% of reports were due to infection
Many others were due to unrelated deaths
Other causes for reports are listed below:
TUOHY Detached from hub 1/31/18
CSF Leak during implantation 1/30/18, 11/2/17, 8/4/17
SUBCUTANEOUS HEMATOMA/PAIN- device explanted 1/26/18
EPIDURAL HEMATOMA- Device Explanted 1/26/18
PARALYSIS ONE LEG AFTER IMPLANTATION- Device explanted 2/01/18
WOUND HEALING ISSUES AT POCKET- Device explanted 1/30/18, 1/2/18
WOUND HEALING ISSUE AT POCKET- antibiotics given, wound debrided 1/24/18, 1/4/18, 1/5/18
WOUND HEALING ISSUE AT POCKET- pocket revision- no explant 1/17/18
WOUND HEALING ISSUE AT LEAD INCISION- 1/3/18
INFECTION AT LEAD INCISION SITE- device explanted 1/22/18, 1/5/18, 2/1/17, 11/18/16, 4/12/16, 9/13/16
INFECTION AT LEAD INCISION SITE- no explant 12/23/16
INFECTION AFTER IMPLANTATION- device explanted 1/26/18
HOSPITALIZED DUE TO CSF LEAK- blood patch 1/2/18
EROSION OF DEVICE THROUGH SKIN- IPG repositioned 1/25/18
EROSION OF ANCHORS/LEAD INCISION SITE- explanted due to patient being thin 1/9/18
INFECTION OF STIM SYSTEM FROM CELLULITIS OF LEGS- explanted 1/11/18
PATIENT FELL- INCISION OPENED, BECAME INFECTED- explanted 12/18/17
BLOOD CLOT FORMED AROUND DEVICE AFTER IMPLANT, PLACING PRESSURE ON A NERVE RENDERING ONE LEG IMMOBILE- explanted 1/19/18
INFECTION IPG SITE- not explanted 1/17/18, 10/10/17, 3/20/17, 11/21/17
INFECTION IPG SITE- explanted 1/16/17, 10/3/17, 1/16/18, 7/14/17, 1/10/18, 1/5/18, 10/17/17, 1/26/16, 9/8/15, 9/1/17, 8/10/17, 6/5/17, 8/1/17, 8/15/17, 2/23/17, 10/5/16, 2/16/16, 10/14/16, 11/30/16, 5/12/17, 11/09/16, 2/24/17, 12/27/17, 12/26/17, 3/17/16, 1/29/16, 8/30/17, 12/20/17, 12/21/17, 9/17/16
ITCHING THROUGHOUT BODY- 2 Nevro devices explanted 11/30/17
INFECTION IPG DUE TO FISTULA FORMING BETWEEN POCKET AND PREVIOUS INFECTION SURROUNDING SPINAL HARDWARE- device explanted 1/16/18
SECONDARY INFECTION of POCKET FROM UTI- explanted 1/5/18
LOW IMPEDENCE- New pain bil LE- explanted 11/30/17
SEROMA AT IPG- drained - no explantation 12/28/17, 12/28/17, 12/8/17
HEMATOMA IPG SITE- no explantation 11/10/17