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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 Contamination (1120); Fluid Leak (1250); Device Ingredient or Reagent Problem (2910); Material Integrity Problem (2978)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/10/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal clonidine (concentration and dose unknown) and compounded baclofen 100 mcg/ml (dose unknown) via an implanted pump. It was reported the event occurred post-operative on (b)(6) 2022. It was further reported the patient had withdrawal issues. Environmental/external/patient factors that may have led or contributed to the issue included possible piece of scar tissue in the catheter or the catheter was nicked with bovie causing withdrawals. Diagnostics/troubleshooting performed included multiple 30% one time bolus and no resolution. Actions/interventions included pump was contaminated in the operating room (or) and replaced. Once pump pocket was opened there was bloody cerebrospinal fluid (csf) return. It was noted there was a possible nick in catheter and drug was leaking out subcutaneous. A new pump and new pump segment were placed. The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. The patient¿s weight and medical history were asked and would not be made available. Additional information was received from a healthcare provider (hcp) via a company representative (rep) on (b)(6) 2022 indicated regarding the pump being contaminated in the or, it was reported the doctor grabbed a handle of something that was not draped and grabbed the pump after he pulled it out of the patient. The pump and pump segment were replaced on (b)(6) 2022. Regarding the date the catheter was nicked and the patient started having withdrawal, it was reported this occurred on (b)(6) 2022. The doctor did not want to send back the pump segment or pump and it was discarded/destroyed.
 
Manufacturer Narrative
Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter. Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 29-sep-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 Key14048335
MDR Text Key290289194
Report Number3004209178-2022-04407
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 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/28/2021
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: 04/07/2022 Patient Sequence Number: 1
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