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

Model Number 8637-20

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8870, serial# unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient, manufacturer's representative (rep), and healthcare professional (hcp) regarding a patient who was receiving 4 mg/ml dilaudid at 0.5 mg/day via an implantable infusion pump for failed back surgery syndrome and spinal pain.It was reported that the patient would hear intermittent beep, and wasn't sure if it was from the pump.The patient's pump was refilled for the first time on (b)(6) 2017, and the patient was scheduled for a recheck on (b)(6) 2018.The patient stated the pump was not helping them with their pain.The patient described hearing a multitone intermittent alarm.The hcp reported the patient presented to the emergency room with allegations of an alarm being heard and no pain control.The rep reported that the empty pump alarm and low reservoir alarm occurred.It was reported that the empty/low reservoir alarms seemed to be erroneous.The logs show that a refill occurred on (b)(6) 2017 at 11:29 and a low/empty reservoir alarm occurred on (b)(6) 2017 at 11:30.It was reported that the erroneous alarms could be related to the software card version of the 8840 that was used to update the pump.The alarm was silenced.The rep reported they would find out what software card is being used in the hcp's office.No further complications were anticipated/reported.

Manufacturer Narrative

Concomitant medical products: the main component of the device system; the other relevant components include: product id: 8870aau01, serial# (b)(4) product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the office that interrogated the pumps did have the updated software cards.The patient's pump was read again and everything looked normal.The software card serial number was provided.The cause of the erroneous reservoir volume was unknown.The alarm was silenced as the pump was correctly dispensing medicine.The patient was seen on 2018 (b)(6) and there were no alarms.The patient's weight was unknown.No further complications were anticipated/reported.

Manufacturer Narrative

Concomitant medical products: product id 8870aau01, serial# (b)(4), product type software; product id 8840, serial# (b)(4), product type programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) indicated the serial number of the 8840 that was used to interrogate the pump when the erroneous alarms were noted was (b)(4).It was noted that the 8840 was no longer in use.It was noted that the 8840 has not been returned.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
• MDR Report Key: 7164626
• MDR Text Key: 97068176
• Report Number: 3004209178-2018-00227
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR