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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 8637-20
Device Problems Separation Failure (2547); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/29/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
References the main component of the device system; the other relevant components include: product id: 8780, serial# (b)(4), product type: catheter. Patient code applies to the catheter. Device code apply to the catheter. Eval code-conclusion code applies to the catheter. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a company representative regarding a patient receiving morphine 1mg/ml for a total dose of 0. 25mg/day via an implantable pump for non-malignant pain. It was reported on (b)(6) 2016 patient was having initial catheter and pump placement. It was noted they replaced the initial catheter. Intervention occurred as healthcare professional (hcp) introduced catheter into the intrathecal space, but had difficulty steering it. Hcp pulled it out along with the needle and found the guide wire extruded out of the catheter. It was noted issue was resolved at time of report and patient status was alive-no injury. It was noted there was no injury related to the issue described. It was noted no troubleshooting or diagnostics were performed. It was also stated there was no factors that may have led, contributed, or caused the issue. It was stated rep was present at the moment the hcp was introducing the catheter. Both the hcp and rep were notified of what happened.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received on 2017-jan-11 from a company representative stated rep was present when this occurred and the device was sent to medtronic for analysis.
 
Manufacturer Narrative
The event was a product problem only. The intervention required box should not have been checked. The event was incorrectly reported as a serious injury and should be reported as a malfunction.
 
Manufacturer Narrative
The catheter was returned for analysis. Analysis of the catheter found damage to the guidewire that occurred during the implant procedure. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6217582
MDR Text Key102622049
Report Number3004209178-2017-00013
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,Followup,Followup
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2016
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: 01/02/2017 Patient Sequence Number: 1
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