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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 Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem Twiddlers Syndrome (4563)
Event Date 03/18/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780 serial# (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-feb-2023, udi#: (b)(4). (b)(4). And eval code conclusion code: are applicable to the catheter. 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 (rep) regarding a patient receiving intrathecal dilaudid 4500 mcg/ml at 216 mcg/day via an implanted pump. It was reported the event/difficulty occurred on (b)(6) 2022 during a procedure. It was further reported the patient was twiddling and the pump flipped. The doctor wanted to check the pump for damage. Diagnostics/troubleshooting included could not aspirate from the side port. The image provided showed twisting of the catheter. A full replacement was completed on (b)(6) 2022 and the catheter was discarded. The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. The patient¿s weight and medical history were asked and would not be made available.
 
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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 Key13870583
MDR Text Key289102244
Report Number3004209178-2022-03666
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 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2021
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: 03/23/2022 Patient Sequence Number: 1
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