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

Model Number 8637-20

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problems Fall (1848); Visual Disturbances (2140); Dizziness (2194); No Known Impact Or Consequence To Patient (2692)

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 healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient who had been receiving 12 mg/ml of hydromorphone at 2.39 mg/day via an implantable pump.It was reported that the pump had been empty for 6-8 weeks.The patient saw a new physician and the physician intended to replace the pump.The hcp did a myelogram and aspirated the catheter successfully.The reservoir was filled with saline and dye and the hcp was planning on bringing the patient back to check on the accuracy of the pump.The catheter was primed and the pump was reprogrammed.It was noted the medication in the pump tubing was never aspirated.Calculations were reviewed so the rep could inform the physician how much medication the patient would receive.The patient was on oral medications and no symptoms were reported.It was later reported the physician was going to contact the patient and program the pump to minimum rate mode.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer and healthcare provider via the manufacturing representative.The patient reported the pump went empty about 7 weeks earlier, relative to the day of the report ((b)(6) 2020).The cause of the empty pump was provided as patient non-compliance.It was further verified the doctor did not intend to replace the pump.It was reported the doctor had stopped the pump from running about two hours in (after the pump was refilled with saline) so the patient received about 1.7 mg of 3.468 mg of drug that would have been in the pump tubing.The patient experienced lightheadedness, was "seeing an aura," and later that evening had a fall which resulted in a trip to the emergency room and five stitches.The pump was placed in minimum rate mode.The patient was back on the day of the report ((b)(6) 2020) and was feeling well.The healthcare provider wanted to start the patient back on therapy.Priming considerations were reviewed.

• 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: 10014552
• MDR Text Key: 189581244
• Report Number: 3004209178-2020-07941
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• 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: 04/30/2020
• Date Device Manufactured: 07/14/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR