FDA.reportPublic FDA data

MAUDE MDR 6000074

MDR report key
6000074
Report number
3005025697-2016-00011
Event key
0
Event type
3
Date of event
2016-09-12
Date received
2016-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LISA PRITCHARD
Address
2800 PATTON ROAD SAINT PAUL MN 55113 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAESTRO RECHARGEABLE SYSTEMPOSTERIOR LEADENTEROMEDICS, INC.PIM2200P-47E2200P-47EC4-07889Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-0501. R

Event Narratives#

N

Patient 1

DEVICE REMAINS IMPLANTED.

D

Patient 1

A SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL (SUBJECT ID (B)(4)) UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. ON (B)(6) 2015, THIS SUBJECT UNDERWENT REPLACEMENT OF THE ANTERIOR LEAD AND RECHARGEABLE NEUROREGULATOR, WITH NO REPLACEMENT OF THE POSTERIOR LEAD AT THAT TIME. ON (B)(6) 2016, THE SITE REPORTED THAT THE PATIENT HAD A FLASHING RED LIGHT DURING ATTEMPTED CHARGING. DURING A CLINIC VISIT ON (B)(6) 2016, AN ERROR MESSAGE (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD) WAS ENCOUNTERED. THIS CODE WAS CLEARED DURING THE VISIT. LATER IN THE DAY ON (B)(6) 2016, THE SUBJECT AGAIN REPORTED A FLASHING RED LIGHT. ON (B)(6) 2016, THE SUBJECT WAS AGAIN SEEN IN THE CLINIC. SEVERAL ERROR MESSAGES WERE ENCOUNTERED (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD, CODE 25: TOO MANY THERAPY RETRIES, AND CODE 3: HIGH IMPEDANCE). THIS SUBJECT IS NOT RECEIVING THERAPY FROM THE DEVICE.

D

Patient 1

A SUBJECT PARTICIPATING IN THE (B)(6) CLINICAL TRIAL (SUBJECT (B)(6)) UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. ON (B)(6) 2015, THIS SUBJECT UNDERWENT REPLACEMENT OF THE ANTERIOR LEAD AND RECHARGEABLE NEUROREGULATOR, WITH NO REPLACEMENT OF THE POSTERIOR LEAD AT THAT TIME. ON (B)(6) 2016, THE SITE REPORTED THAT THE PATIENT HAD A FLASHING RED LIGHT DURING ATTEMPTED CHARGING. DURING A CLINIC VISIT ON (B)(6) 2016, AN ERROR MESSAGE (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD) WAS ENCOUNTERED. THIS CODE WAS CLEARED DURING THE VISIT. LATER IN THE DAY ON (B)(6) 2016, THE SUBJECT AGAIN REPORTED A FLASHING RED LIGHT. ON (B)(6) 2016, THE SUBJECT WAS AGAIN SEEN IN THE CLINIC. SEVERAL ERROR MESSAGES WERE ENCOUNTERED (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD, CODE 25: TOO MANY THERAPY RETRIES, AND CODE 3: HIGH IMPEDANCE). THIS SUBJECT IS NOT RECEIVING THERAPY FROM THE DEVICE. UPDATE: THE POSTERIOR LEAD AND RECHARGEABLE NEUROREGULATOR WERE REPLACED ON (B)(6) 2016. NO ISSUES WERE ENCOUNTERED DURING THE REVISION PROCEDURE.