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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); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/26/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving fentanyl, morphine, bupivacaine via an implantable pump for unknown indications for use. It was reported that on (b)(6) 2022 during the worst pain, the patient noted boluses do not manage pain well but still uses them all. The patient reported inadequate pain relief from boluses. The device was reprogrammed where the morphine was increased by 1mg.   the outcome was noted as ongoing.   the clinical diagnosis was inadequate pain relief from boluses.   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 relatedness to the drug (bupivacaine, morphine, and fentanyl) was related, and the drug action that caused the event was increased dose. Additional information was received from the healthcare provider via a clinical study indicated that a failed dye study occurred and surgical revision was required. The catheter was dislodged and coiled in the midline and the tip was in the lumbar spine.
 
Manufacturer Narrative
Concomitant products: product id: 8784, product type: catheter. 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 Key13994558
MDR Text Key288479852
Report Number3004209178-2022-04189
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 Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
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 Received07/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2021
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: 04/04/2022 Patient Sequence Number: 1
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