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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 08/03/2018
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 professional (hcp) regarding a patient who was receiving hydromorphone, 20 mg/ml concentration at 5. 3 mg/day dose, clonidine, 200 mcg/ml concentration at 53 mcg/day dose and bupivacaine, 10 mg/ml concentration at 2. 65 mg/day dose via intrathecal drug delivery pump for non-malignant pain. It was reported that actual reservoir volume (arv) was greater than expected reservoir volume (erv); arv:35, erv: 18. 2, date: (b)(6) 2018, arv: 32 and erv: 26. 7. The hcp stated that they would be bringing the patient back early to check the volumes. Increase in pain was reported. No further complications were reported.
 
Manufacturer Narrative
Continuation of concomitant products: product id 8709, serial# (b)(4), implanted: (b)(6) 2003, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported that the cause of volume discrepancy was probable occlusion of the catheter. Patient took oral morphine for pain. The hcp would have the patient come in, remove hydromorphone, replace with normal saline, the hcp would have the patient return 2 weeks later to do catheter patency test. 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 professional (hcp) via manufacturer representative (rep). It was reported that volume discrepancy at refill occurred, too much medication was pulled from the pump. The rep was not aware of any environmental/external/patient factors that may have led or contributed to the issue. Patient's pump was filled with normal saline and would be allowed to run for a few weeks to purge the system prior to a dye study. A dye study was scheduled for (b)(6). At the time of this report, the issue was not reported and patient status was alive-no injury. No further complications were reported.
 
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 Key7763346
MDR Text Key117020020
Report Number3004209178-2018-17552
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 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/21/2017
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: 08/08/2018 Patient Sequence Number: 1
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