• 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 Human-Device Interface Problem (2949); Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994); Vomiting (2144); Chills (2191); Therapeutic Response, Decreased (2271); Malaise (2359); Sweating (2444); Shaking/Tremors (2515)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer¿s representative (rep) and a patient regarding their implantable drug infusion device. The drugs being delivered were 750 mcg/ml fentanyl at 225. 16 mcg/day, 25 mg/ml hydromorphone at 7. 505 mg/day, 1,500 mcg/ml clonidine at 450. 3 mcg/day, and 15 mg/ml bupivacaine at 4. 503 mg/day. The reason for use was spinal pain. It was reported that the patient was feeling cold and having some pain. The issue started on (b)(6) 2018. The patient does not think their pump is working. The rep just read the pump and the logs look fine. The managing healthcare professional (hcp) just did a refill and everything looked fine. The hcp confirmed there to be no issues with the system. The patient did recently start oral meds (movantik) for their constipation and the hcp is thinking this may be the reason why the patient is having symptoms and does not believe it is the pump. Additional information was received on 2018-jul-16. It was reported that the dose of fentanyl was 375. 46 mcg/day, hydromorphone was 12. 015 mg/day, clonidine was 750. 9 mcg/day, and bupivacaine was 8. 11 mg/day. Withdrawal symptoms were reported. No interventions were mentioned. The patient stated, "for the past couple of months, when i would give myself a bolus i would get very ill and i would throw up violently, have sweats, have tremors and this made me fall so now i am in the hospital due to a fall". Withdrawals symptoms started "2-3 months ago on and off" (2018) and had a fall on (b)(6) 2018 and is in the hospital due to the fall, as well as his withdrawal symptoms. The patient has not missed any refills. The hospital that he is at has given him oral medication to combat the withdrawal and "i feel fine" since he has been taking the medication. When asked about hearing alarms, the patient stated, "i thought i was, but wasn¿t sure if it was my phone or not. ¿ the patient thinks it was the critical alarm that he heard, and says this occurred "a couple months ago about the same time as the withdrawal. ¿ the patient was advised that they should consult with the hcp about his withdrawal and fall, and that the hcp should investigate what is causing this issue. The situation is being addressed by the hcp. There were no further complications 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 Key7777652
MDR Text Key116921800
Report Number3004209178-2018-18081
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,consum
Reporter Occupation
Type of Report Initial
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/08/2015
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: 08/13/2018 Patient Sequence Number: 1
-
-