MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 12438271
• MDR Text Key: 270274213
• Report Number: 3004209178-2021-13466
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• 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 Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/14/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial