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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Pain (1994); Scar Tissue (2060); Numbness (2415); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8703w, lot# l78719, implanted: (b)(6) 2000, product type: catheter. Other relevant device(s) are: product id: 8703w, serial/lot #: (b)(4), ubd: , udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2021-aug-30, information was received from a patient receiving bupivacaine (6. 126 mg/day) and dilaudid (13. 987 mg/day) via an imp lantable pump for spinal pain. The patient reported that starting a couple of years ago, the have been having a problem "where the catheter goes into the spinal cord". The patient stated their surgeon calls it "an aneurysm, others call it a cyst". The patient stated that because of the "cyst", [the patient] gets "nerve pain, like someone's shocking [them]". The patient stated the "electrical shock goes around bad in my back on the right side". The patient stated that due to the "shocking", they rub that side and have "rubbed myself so hard" that they have scars on that side. The patient stated they have lost feeling totally on the left side from the waist down and in their privates. The patient called due to inquiries related to the catheter. The patient was redirected to their hcp to further discuss their medical concerns. The patient then mentioned that on wednesday, the hcp decreased the medication to attempt to shrink the "cyst". The patient stated their current dose of dilaudid was 13. 987 and bupivacaine was 6. 216 and stated the previous dosage had been that way "for years". The patient called back and reported they wanted to take the medication out of the pump for 6. 8 months and see if it goes away. The patient stated they did not want to go back to oral medications. The patient stated they have scars on her from her holding her pain which is nerve pain. The rolls of manufacturer representative (rep), healthcare professional (hcp) and the manufacturer were reviewed. The patient was redirected to their hcp. Additional information was received from the healthcare provider via a device manufacturer representative indicated that the patient had a possible granuloma at tip of the catheter and that the patient wanted it replaced.
 
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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 Key12438271
MDR Text Key270274213
Report Number3004209178-2021-13466
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,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/14/2022
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 Received09/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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