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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Device Ingredient or Reagent Problem (2910)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer¿s representative regarding a patient who was currently receiving bupivacaine [8 mg/ml] at a dose of 3 mg/day and morphine [8 mg/ml] at a dose of 3 mg/day via an implantable pump for non-malignant pain.It was indicated that saline was the new drug in the pump.It was reported on (b)(6) 2017 that the patient switched physicians and that (b)(6) 2017 was the patient¿s first appointment with the new doctor.It was noted that the patient was complaining of no pain relief and it was asked but unknown if it was considered a sudden or gradual change in therapy/symptoms.The exact date of the onset was unknown and was stated to be happening prior to (b)(6) 2017.It was noted that the patient¿s previous managing physician was in the process of titrating the pump medication dose to reach effective pain relief when the patient decided to switch managing physicians.It was indicated that the patient¿s reason for changing managing physician was unknown.It was reported that on (b)(6) 2017 the hcp aspirated the catheter and drew back some blood.It was explained that sometimes when the needle punctures the skin some blood could get into the needle.It was asked if that could mean that the catheter had moved and was in the epidural space, and it was recommended in response that they put dye in the catheter to confirm placement.It was indicated that no diagnostics were performed related to the lack of pain relief and that no troubleshooting was performed related to the blood that was drawn back from the catheter.The cause of the blood getting drawn back from the catheter was unknown.The issue was not resolved but the patient was referred to a neurosurgeon for examination.The patient¿s weight at the time of the event was unknown.No further complications were reported or anticipated.

Manufacturer Narrative

Device code (b)(4) does not apply.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6481826
• MDR Text Key: 72613013
• Report Number: 3004209178-2017-08047
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Date Device Manufactured: 10/11/2016
• 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: 58 YR