• 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 Contamination (1120); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8551, serial#: unknown, product type: accessory. Other relevant device(s) are: product id: 8551, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving dilaudid (10 mg/ml, 0. 480 mg/day) via intrathecal drug delivery pump for non-malignant pain and chronic low back pain. It was reported that the case was done with a contaminated instrument set. After the fact it was identified a filter was not in the lid of the set. There were no environmental/external/patient factors that may have led or contributed to the issue. No diagnostics/troubleshooting were performed. An explant was planned for (b)(6) 2018 at 1400. The patient status was 'alive - no injury. ' the issue was not resolved. The explanted pump would be returned. There were no reported symptoms. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional via manufacturer representative. It was reported that the hcp denied needing the rep's presence for the explant. The hospital was going to keep the catheters and pump for their analysis, and would not return them to the manufacturer. No further complications were reported.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional. It was reported that the contamination was referring to the missing filter. One of two filters was missing from the surgical kit, not from a manufacturer's kit - the surgical instruments were lacking a filter. 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 Key8006371
MDR Text Key125097390
Report Number3004209178-2018-23944
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
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 Received11/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/12/2018
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: 10/25/2018 Patient Sequence Number: 1
-
-