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

Model Number 8637-40

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 who was receiving an unknown drug at unknown dose and concentration via intrathecal drug delivery pump. The indication for use was noted as lumbar radiculopathy and spinal pain. It was reported that there was pain pump failure. No symptoms were reported. There were no further complications reported at this time.

Manufacturer Narrative

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

Manufacturer Narrative

The evaluation code method has been updated. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer on (b)(6) 2019. It was reported the patient's pump was malfunctioning and beeping. The consumer reported that when the patient would go in for a drug test the amount that was registered was a lethal amount. The consumer stated, "it's spitting out medication because he's not taking any. " the consumer stated the pump would not work for months at a time and they did not know what was wrong. The consumer was directed to follow-up with the healthcare provider. It was reported the issue began at the beginning of the year, 2019. The consumer thought the device was delivering morphine, but they were not sure. They did not know the dose or concentration. No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received via a company representative. The company representative spoke with the patient¿s wife. It was indicated that they needed a code to shut it (pump) down. The patient was no longer a pain patient and didn¿t have a pain physician. It was further noted that the patient has not had a pain physician for over six months and there were no narcotics in the pump. The pump had not been active for most of the year. They just wanted the alarm to stop and someone told them they could do that for her. It was noted that someone from the manufacturer told them a month ago they would meet her at her primary care physician to silence the alarm with a code.

• 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
• MDR Report Key: 7746856
• MDR Text Key: 116722302
• Report Number: 3004209178-2018-17269
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No