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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 Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Material Integrity Problem (2978)
Patient Problems Twiddlers Syndrome (2114); Dizziness (2194); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a device manufacturer representative regarding a patient who was receiving morphine (20 mg/ml at an unknown dosage) via an implantable infusion pump for spinal pain. It was reported that a flipped pump was confirmed. The device manufacturer representative was told that the patient was considered a twiddler. The hcp said that when they went in for revision the pump was not facing the correct direction and it was "all tied and twisted. " a catheter study was done prior to removing the pump. The hcp was able to aspirate 1. 5 ccs of fluid but could not push any dye through the catheter. When the pump was removed, there was supposed to be 1. 5 ml of drug but it actually had 9. 5 ml in the reservoir. No additional patient symptoms were reported. At the time of the report, the pump had been set to minimum rate. The pump was removed on (b)(6) 2018, but it was unknown when the patient began experiencing issues with the pump flipping. The product was going to be returned to the manufacturer for analysis. 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 a healthcare provider (hcp) via a device manufacturer representative. It was reported that the cause of the catheter becoming twisted/tied was due to the patient's pump flipping numerous times and it became twisted. Twiddlers syndrome was also noted. The pump and catheter were completely removed and were sent to medtronic for evaluation on 2018-apr-18.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the patient was "a flipper. " the patient started having problems in (b)(6) 2017. The hcp tested the catheter and found the volume was expected to be 1. 5 ml and actually was 9. 5 ml. Symptoms included dizziness and lightheadedness. The pump flipped and was with a tangled catheter. A rotor study was performed and was noted to be "good. " a dye study was also performed. No further complications were reported.
 
Manufacturer Narrative
The pump was returned, and analysis found no anomaly. The catheter was returned, and analysis found the catheter body had significant twisting that may have affected infusion. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7441632
MDR Text Key105873750
Report Number3004209178-2018-08353
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508149
UDI-Public00643169508149
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 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2017
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: 04/18/2018 Patient Sequence Number: 1
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