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

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Distress (2329); Electric Shock (2554); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot#: l57101, implanted: (b)(6) 1999, product type: catheter, product id: 8709, lot#: l57101, implanted: (b)(6) 1999, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), udi#: (b)(4).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 an unknown intrathecal medication via an implanted pump for spinal pain.It was reported the pump was nearing the end of its normal battery life and the patient decided to "eliminate the pump" so the healthcare provider (hcp) had been turning medication down.It was reported "something was not right" because the last time the patient went in to have medication removed from pump and saline put in, the hcp told the patient they would feel the withdrawal symptoms in 10 days.It was noted on (b)(6) 2022, when they put the saline in it, the patient came home and within 8 hours felt like electricity jolts in their body 3-4 times and then the patient felt severe withdrawal symptoms that "knocked me¿.It was noted the patient was so much pain, they went to the emergency room (er) at the va who told the patient it was withdrawal and gave the patient intravenous (iv) dilaudid.It was reported the patient did not know and now they were going through withdrawal again.It was noted the patient had withdrawal symptoms before but nothing like this and reported "this was the worst thing i've ever had in my whole life; i've gone through and am still going through hell 6 days afterwards".The patient reported, "i'm so upset, they told me 10 days after they put the saline in last time i would probably go through some withdrawal, nothing this quick".The patient was scared they would have to do this again.It was noted the patient would tap on the pump and it sounded empty, so the patient thought maybe the entire contents of the pump already went through the catheter, or the catheter became unhooked.The patient was looking for answers and was redirected to the hcp.It was reported, "something is screwed up big time".

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13367106
• MDR Text Key: 295606311
• Report Number: 3004209178-2022-01276
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2022
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male