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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Shock (2072); Numbness (2415); Alteration In Body Temperature (2682)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

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 dilaudid via an implanted infusion pump.It was reported that yesterday the patient's back where the catheter goes in was hurting really bad and was cold.The patient's hands then got numb and they were very concerned.The patient was redirected to the hcp.Additional information received from a consumer reported the patient tried to mow the lawn for the first time this year and hurt their back.The patient had to go to bed and they think they went into shock.The hcp saw the patient the next morning and they increased the dose by 13%.It was noted the pain and cold/numbing went away at the same time but the patient still had a pain level of 5 and couldn't do much.The patient's weight was (b)(6).

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer reported the cause of the catheter site being cold and hurting with numb hands was undetermined.It was noted the patient was placed on bed rest.It was noted that the catheter site being cold and hurting and numb hands was not resolved.It was noted that 24 hours later the patient was okay.No further complications were reported.

• 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: 10013901
• MDR Text Key: 189477654
• Report Number: 3004209178-2020-07917
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Date Device Manufactured: 04/22/2019
• 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 Age: 70 YR
• Patient Weight: 104