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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 Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Numbness (2415); Spinal Cord Injury (2432); Ambulation Difficulties (2544); Spinal Arachnoiditis (4416); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-aug-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer's representative regarding a patient receiving morphine (10. 0 mg/ml at 0. 8 mg/day) and bupivacaine (10 mg/ml at 0. 8 mg/day) via an implanted pump. It was reported the pump had been turned off early in (b)(6) when the patient had surgery to remove the catheter due to numbness and paralysis of their lower extremities. According to the patient, they were admitted into the hospital, on (b)(6) 2020, and taken to surgery, on (b)(6) 2020, to remove the it catheter. It was noted the pump was turned off at that time. After interrogating the pump post mri, it was found to still be programmed at a simple continuous mode. However, motor stalls were present in the interrogation report on (b)(6) 2020. The current status of the catheter location was unknown. According to the hospital post op note, it stated that the catheter was removed from the intrathecal space, however, the exact location and existence of the catheter was unknown. There were no known factors known. It was noted the issue was resolved.
 
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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
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key10845122
MDR Text Key216416382
Report Number3004209178-2020-20049
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/20/2019
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: 11/16/2020 Patient Sequence Number: 1
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