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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 Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Pain (1994); Discomfort (2330); Malaise (2359); Meningitis (2389); No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, product type: catheter. Product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. 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 saline via an implantable infusion pump. The indication of use was failed back surgery syndrome and spinal pain. It was reported the patient passed away from bacterial meningitis that he got when he was getting the pump implanted. The lining of the patient's brain, spinal cord, and spinal fluid were all contaminated by the bacteria that flourished. He became ill and was transferred to a local hospital. The patient was transferred to hospice and passed away within hours of arrival. It was asked but unknown if autopsy records were available and the patient would be cremated in several days. It was noted that the patient had "many surgeries and stuff going on". The patient had never received any medication from the pump. Additional information was received from the healthcare provider (hcp). It was reported that they attempted to place the device on (b)(6) 2018, but were unable to achieve dural penetration despite multiple attempts and angling and elected to abort the procedure given the high level of attempts to reposition the needle. There was no additional information regarding the aborted procedure. The physician had nothing to report regarding the implant surgery other than they did not fill the pump after surgery with hydromorphone as anticipated and the pump remained with the sterile water that it came with. It was later reported that the patient reported right rib pain and lower abdominal discomfort after pump implant on (b)(6) 2018. No further complication was reported.
 
Manufacturer Narrative
(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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7484329
MDR Text Key107269340
Report Number3004209178-2018-10027
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,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2018
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: 05/03/2018 Patient Sequence Number: 1
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