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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Occlusion Within Device (1423); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. 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 an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain. It was reported that during a refill on (b)(6) 2018, the patient had a high residual volume of 37 ml aspirated from the pump. The patient had poor pain relief. There were no known environmental, external or patient factors that may have led or contributed to the issue. No diagnostics or troubleshooting were performed, and no interventions were taken to resolve the issue. Surgical intervention did not occur and it was unknown whether it was planned. The issue was not resolved and the patient status was "alive - no injury" at the time of this report. No further complications were reported. Additional information was received from the healthcare professional via manufacturer representative. It was reported that the expected residual volume at refill was 2 ml. Surgical intervention was not planned. 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 old catheter was twisted and kinked at the spinal site. The distal end was left in-situ and tied off, and the remaining catheter was removed. The pump was flipped in the pocket and the sutures were broken. The old pump was removed. A new pump and catheter were implanted. No alarms were noted. 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 product was not returned; the customer sent it to pathology per hospital protocol and did not request analysis. No further complications were reported.
 
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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 Key7511255
MDR Text Key108644126
Report Number3004209178-2018-10817
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 06/14/2018
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 Date09/28/2018
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 Received06/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/08/2017
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
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