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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 Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Deposits (1809); Fall (1848); Loss of consciousness (2418); Sleep Dysfunction (2517)
Event Date 10/11/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6)2010, product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-aug-2011, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving bupivacaine (15 mg/ml) and dilaudid (30 mg/ml) via an implanted pump. The indication for pump use was non-malignant pain. The patient reported that last monday ((b)(6) 2021) he went for a catheter dye test and when the hcp (healthcare provider) went to pull on it ¿it was negative, he finally got a little bit then he tried again¿. Per the patient he went home after the procedure and was ¿very restless¿ and he ¿fell on the floor¿. At some point, he ¿completely passed out¿ and his neighbor found him on the floor and called 911. He stated that ¿they shot me with some narcan, and it helped¿. His physician told him that at the end of the catheter ¿it can grow crystals in that area¿ and ¿apparently when he did the dye study it blew all the crystals out and caused the overdose¿. On wednesday ((b)(6) 2021), the pump was turned down by 40% at the hospital. The patient mentioned that the pump was last increased 7 to 8 months ago. He stated that he was due to have his pump replaced in 4 or 5 months and was wondering if they should replace it now.
 
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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 Key12655948
MDR Text Key277118693
Report Number3004209178-2021-15528
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2015
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: 10/19/2021 Patient Sequence Number: 1
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