• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Failure to Deliver (2338); Insufficient Information (3190)
Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)
Event Date 07/04/2018
Event Type  Injury  
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6)2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving gablofen (1000 mcg/ml, 380 mcg/day) via an implantable infusion pump. It was reported that the patient showed up to the emergency room in baclofen withdrawal. There was not any environmental/external/patient factors that may have led or contributed to the issue. Side port aspiration was performed but the hcp decided that either the catheter or pump was not working and thus both were replaced. The hcp did a prepontine catheter placement with the new catheter and was connected to ascenda catheter using a shunt. The connection was made by using a collet connector from an 8785 kit and peeling away the plastic and only using the pin. He also used a plating system to fasten the shunt distal segment to the head. The issue was resolved and patient status was alive with no injury at the time of the report. No further complication was reported.
 
Manufacturer Narrative
Evaluation of the pump and catheter showed no significant anomalies. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Continuation of concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter; product id: 8578, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter; product id: 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type: catheter; section 'device' information references the main component of the system. Other relevant device(s) are: product id: 8578, serial/lot #: (b)(4), ubd: 31-mar-2018, udi#: (b)(4), product id: 8709, serial/lot #: (b)(4), ubd: 28-jun-2006, udi#: (b)(4). New coding applies to pump(8637-40) and catheters(8578, 8709). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The pump was received with no documentation. The indication of use was intractable spasticity and cerebral palsy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7680548
MDR Text Key113740700
Report Number3004209178-2018-15532
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
-
-