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

Model Number 8637-20

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, information was received from a patient receiving hydromorphone (15.0 mg/ml, 1.650 mg/day), bupivacaine (10.0 mg/ml, 1.100 mg/day) and morphine (25.0 mg/ml, 2.750 mg/day) via an implantable pump for non-malignant pain.Beginning a couple months ago in 2018, the patient was in a rehabilitation facility and they wouldn¿t allow the patient to get their pump filled.The alarm went off and the "facility didn't care".The alarm started out as the single tone alarm and then it got louder and turned into a dual alarm.The patient then stated their pump ran dry.Additional details stated the pump was refilled and it was dry.The patient also stated that the pump was about half full.The patient reported that they had been putting in a little bit of medication at a time.The patient said it was extremely painful and they didn't understand why it wasn¿t working.The patient said they needed to be increased 25%.The patient also said they needed to get the pump filled all the way.The patient was in extreme pain.The patient indicated they took oral medication and they didn¿t have that either.The patient took tamazapan for their neuropathy pain and stated they were running out of medication.The patient then indicated they had moved because they could get better care.The patient indicated they went to the hospital about 10 days ago and they gave her a one-time refill of oral medications.They also gave the patient a referral for a primary care healthcare professional (hcp).The patient had an appointment for (b)(6).The patient's pain was indicated as gradual as it would start in the morning and was getting worse.The patient said "the pain is getting worse" and they didn¿t think they could make it.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7565643
• MDR Text Key: 110044675
• Report Number: 3004209178-2018-12480
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Date Device Manufactured: 03/04/2014
• 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 Age: 57 YR