• 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 Premature End-of-Life Indicator (1480); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
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 healthcare provider (hcp) via a company representative regarding a patient receiving morphine (50 mg/ml at 10. 873 mg/day), clonidine (1250 mcg/ml at 271. 8 mcg/day), and marcaine (40 mg/ml at 8. 698mg/day) via an implanted pump. The indication for pump use was spinal pain. It was reported that the pump reached eos (end of service) two days after the eri (elective replacement indicator) alarm occurred. There were no reported environmental, external, or patient factors that may have led or contributed to the issue. The pump was replaced. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event. The pump activity logs indicated ¿critical alarm¿ pump motor stall occurred¿ on (b)(6) 2021 at 3:23 pm; ¿pump motor stall recovery¿ on (b)(6) 2021 at 4:39 pm; ¿non-critical alarm ¿ elective replacement indicator (eri)¿ on (b)(6) 2021 at 4:32 pm; and ¿critical alarm ¿ end of service (eos) occurred¿ on (b)(6) 2021 at 2:32 pm with a final log on (b)(6) 2021 at 2:32 pm indicating ¿critical alarm ¿ stopped pump duration exceeded 48 hours¿.
 
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key11841449
MDR Text Key251159219
Report Number3004209178-2021-07862
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
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2014
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: 05/18/2021 Patient Sequence Number: 1
-
-