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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 Problem Difficult to Insert (1316)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and healthcare provider (hcp) via a company representative regarding a patient receiving morphine (1. 0 mg/ml at 0. 1999 mg/day) and bupivacaine (0. 7 mg/ml at 0. 13995 mg/day) via an implanted pump. The patient¿s medical history included chronic tailbone and leg pain, lumbar 3-4 fusion with hardware, x-stop placement (lumbar), rickets disease as a child, and bilateral knee replacements. It was reported that after the initial implant procedure the patient woke up in recovery and complained of intense burning pain in both arches of her feet. The patient was inconsolable and crying in pain. Anesthesia sedated the patient in recovery to calm her down. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that during the initial implant procedure, the surgeon did have to reposition the spinal needle one time to gain access to the intrathecal space. The patient had a fusion at l3-4. The surgeon inserted the spinal needle above at l2-3. The remain der of the procedure went without difficulty and the catheter had good csf (cerebrospinal fluid) flow and placement. After the implant and in recovery, the surgeon did access the pump¿s cap (catheter access port) to make sure the catheter was patent and the catheter was aspirated without difficulty. The patient was then taken to mri and no abnormalities were found. After the mri and 30-45 minutes in recovery with iv (intravenous) pain medication not helping, the surgeon decided to take her back to surgery and revise the spinal segment of the catheter and fill the pump with medication. It was filled with pfns (preservative free normal saline) during the initial implant. During the catheter revision, the old spinal segment was removed and replaced with a new spinal segment from a revision kit. The surgeon had no difficulty with the catheter insertion. Once the tip was at t10, he anchored and attached the new segment to the existing pump segment. The revised catheter was aspirated and had good flow. The pump was filled with morphine and bupivacaine during the procedure. The patient was taken back to recovery and when she woke up this time, she still complained of burning in the arches of her feet, but it was not as intense. The patient then received a 0. 2 mg single bolus, and this helped with the patient¿s pain. The surgeon gave another 0. 2 mg bolus following the first and the patient stated that the burning pain was ¿letting up¿. The patient was then sent up to the surgical floor of the hospital for overnight observation. Today (b)(6) 2021, the surgeon saw the patient in the hospital and said she was 90% better and was going home. The patient was to have an office follow up visit with the surgeon in about a week. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11259105
MDR Text Key229639007
Report Number3004209178-2021-01733
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 company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2022
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/06/2020
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: 02/01/2021 Patient Sequence Number: 1
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