FDA.reportPublic FDA data

MAUDE MDR 9897781

MDR report key
9897781
Report number
3004209178-2020-06370
Event key
0
Event type
3
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACTIVASTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMORMEDTRONIC PUERTO RICO OPERATIONS CO.MHY3760137601* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. R

Event Narratives#

N

Patient 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT#: V875336 IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: V939307, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: V939307, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37085-60, SERIAL/LOT #: (B)(4), UBD: 03-MAY-2016, UDI#: (B)(4) ; PRODUCT ID: 37085-60, SERIAL/LOT #: (B)(4), UBD: 03-MAY-2016, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: V875336, UBD: 26-AUG-2014, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: V939307, UBD: 01-NOV-2014, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: V939307, UBD: 01-NOV-2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IM PLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS INFECTED AND WAS SCHEDULED TO REMOVE ON (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.