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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 Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving morphine (unknown concentration or dose) via an implantable pump for spinal pain indications. It was reported that the patient had pain at the pump area. It was unknown when the pain started. Upon opening pump pocket on (b)(6) 2022, they found kinking and coiling of the catheter. Of note, they could not interrogate the pump pre-operation because the pump was flipped. The hcp cut off the old kinked and coiled catheter and replaced it with a new 8784 piece that was tunneled across the left abdomen of the new pocket site. They primed a new 8784 on the old pump before connecting to spinal segment because they did not get any csf backflow or aspiration from spinal portion.  they checked the reservoir and aspirated more than expected sothey updated the reservoir volume in the tablet to the accurate volume. Same daily dose was kept on programming. Pump logs were checked and pump was ok with no motor stalls.  pocket revision was done. There were no known factors that may have led or contributed to the issue.  the issue was resolved at the time of report. The patient's weight and medical history were asked but unknown. The patient's status at the time of report was alive - no injury.
 
Manufacturer Narrative
Concomitant medical products: product id 8780 serial# (b)(4), implanted:(b)(6) 2021. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4) ubd: 20-aug-2022, udi#: (b)(4). 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13971182
MDR Text Key288681548
Report Number3004209178-2022-04100
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 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/09/2019
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: 03/31/2022 Patient Sequence Number: 1
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