• 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 Problem Kinked (1339)
Patient Problem Muscular Rigidity (1968)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: product id: neu_unknown_cath, lot# unknown, implanted: unknown , product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown, udi#: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional (hcp) and representative regarding a patient in (b)(6). The medication, concentration, and dose via an implantable pump at the time of this event was not reported. The indication for use was not provided. It was reported that the patient¿s catheter was kinked as diagnosed via a revision in (b)(6) of 2018. The ¿kink was taken out¿ at the procedure. Currently, the physician inquired about how to confirm whether a pump was flipped or not. The "tip" or top of the pump was facing medial rather than superior. The patient had claimed to flip their pump back over manually. Troubleshooting was discussed. There were no symptoms reported. No further complications were reported/anticipated. Additional information was requested to determine the relationship potential pump flipping with the previous catheter kink.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Please note similar information had been previously reported in regards to the pump flipping and had already been captured in manufacturing report # 3004209178-2018-10822. Any further information pertaining to the (b)(6) 2018 pump flipping will solely be captured in that event. Going forward this event will solely capture the(b)(6)2018 catheter kink revision and includes: it was reported that the patient¿s catheter was kinked as diagnosed via a revision in (b)(6) of 2018. The ¿kink was taken out¿ at the procedure. In regards to the kink being taken out, the physician had opened in the back and exposed the catheter and disconnect the 2 pieces and was able to get cerebrospinal fluid (csf) flow form the distal catheter. As now reported, nothing was removed. The patient experienced increased spasticity which is why the physician operated on the patient. It was further reported that the catheter model and serial/lot, implant date of the catheter, and the cause of the catheter kink were all unknown. Continued efforts were being made to attempt further information from the physician, but nothing further to date was received. No further complications were reported/anticipated.
 
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 Key7511486
MDR Text Key108168187
Report Number3004209178-2018-10826
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2014
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: 05/14/2018 Patient Sequence Number: 1
-
-