• 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 8637-20
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial #: (b)(4), implanted: (b)(6) 2016, product type: catheter. Product id: 8780, serial #: (b)(4), implanted: (b)(6) 2016, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-oct-2017, udi #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving fentanyl and bupivacaine at unknown concentrations and doses via an implantable infusion pump. The indication for use was noted to be non-malignant pain. It was reported that the patient had been having "problems" and her pump was replaced on (b)(6) 2019. She clarified the problems as "the catheter was doing something when she would give herself a bolus - her left leg would go dead" and she would have to drag her leg when she walked. This began about 6 months prior to the report date. She also noted that her doctor told her she had a granuloma at the end of the catheter for the past couple of weeks, relative to (b)(6) 2019, but "a few days ago" the doctor said he now didn't think it was a granuloma but a "narrowing of the spinal cord" and he wanted to "go in and take out a vertebrae" but instead he replaced the patient's pump. The catheter was left in place. After the replacement the patient noted that from her waist down goes numb and she "falls to the floor. " she had pain from head to toe and her "right leg was giving her problems. " she noted she was seeing her doctor on (b)(6) 2019 for a refill. She was going to bring her concerns up to him then. No further complications were reported.
 
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 Key8470210
MDR Text Key140508924
Report Number3004209178-2019-06408
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/21/2016
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: 04/01/2019 Patient Sequence Number: 1
-
-