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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 Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
On (b)(6) 2022, information was received from a manufacturer representative (rep), regarding a patient receiving lioresal (250 mcg/m l, 177 mcg/day) via an implantable pump for intractable spasticity. It was reported the patient had a catheter replacement due to the fact that the healthcare professional (hcp) could not aspirate from the catheter access port (cap) to attempt a dye study. The reason for the catheter replacement was stated as occlusion and drug not leaving the pump. The rep then reported that upon interrogation of the pump today, before the catheter replacement, the rep noted there was an empty pump reservoir alarm that had occurred on (b)(6) 2022. The rep stated that the patient had 40 ml in the pump when they aspirated the reservoir. The rep believed the pump was last updated on (b)(6) 2022. Additional actions were reviewed. Patient symptoms/ complications were unknown.
 
Manufacturer Narrative
Concomitant medical products: product id: 8731sc; serial#: (b)(4); product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 21-aug-2015, 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 Key14176099
MDR Text Key290466453
Report Number3004209178-2022-05093
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/28/2020
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: 04/21/2022 Patient Sequence Number: 1
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