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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 Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Overdose (1988); Sedation (2368); Decreased Respiratory Rate (2485); No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8551, lot#: unknown, product type: accessory. 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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving an unknown intrathecal drug via an implantable infusion pump. It was reported on (b)(6) 2020 that the hcp thought the refill kits with the component changes were unsafe compared to the previous refill kits, and that the hcp thought they had a recent pocket fill caused by the new refill kit.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received in response to a request for follow-up. It was reported that the drug involved with the reported event was fentanyl 3000 mcg/ml at a dose of 900 mcg/day, bupivacaine 30 mg/ml at a dose of 9 mg/day, and clonidine 600 mcg/ml at a dose of 180 mcg/day. It was also confirmed that no programming changes (other than the reservoir volume) had been made at the refill.
 
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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 MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9950286
MDR Text Key190814759
Report Number2182207-2020-00125
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
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 Received06/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/03/2016
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: 04/10/2020 Patient Sequence Number: 1
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