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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 Obstruction of Flow (2423); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  Injury  
Event Description
Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving clonidine (unknown dose and concentration), compounded baclofen (unknown dose and concentration), dilaudid (hydromorphone) (unknown dose and concentration), and bupivacaine (unknown dose and concentration) via an implantable pump for unknown indications for use. It was reported on (b)(6) 2021 the patient presented to the operating room for a pump replacement secondary to normal end of battery life and an occlusion at the proximal segment of the catheter was observed. The implanting physician was unable to insert the spinal segment in the desired space. The pump segment was coiled in the pump pocket and the pump was programmed to minimal rate. The plan was to refer to a neurosurgeon. On (b)(6) 2021 the existing catheter was removed, and a new catheter was attempted to be implanted but the spinal segment could not be threaded up to the desired level. Therapy was suspended and the pump was programmed to minimal rate. The outcome was noted as ongoing. The device diagnosis was catheter occlusion. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The event date was (b)(6) 2021.
 
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 20-nov-2016, 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 Key12950775
MDR Text Key281837990
Report Number3004209178-2021-18094
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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 Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2014
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: 12/07/2021 Patient Sequence Number: 1
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