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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2022, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 18-oct-2009. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (20 mg/ml at 12. 316 mg/day) and bupivacaine (290 mcg/ml at 178. 58 mcg/day) via an implanted pump. It was reported that during the pump replacement procedure for normal end of life, the catheter was damaged/cut. The surgeon removed and replaced the old pump connector with a new sutureless connector and was able to aspirate after. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be the pump replacement procedure. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14350979
MDR Text Key291343697
Report Number3004209178-2022-06013
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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