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 Diarrhea (1811); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 05/01/2018

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 patient regarding their implantable drug infusion device.The drug being delivered was morphine (unknown) with an unknown dose and concentration.The reason for use was non-malignant pain.It was reported that the pump was alarming or beeping.The patient reported that the pump alarm had been going off since (b)(6) 2018, ¿for several days.¿ the patient could not confirm if it is the critical or non-critical tone.The sound was consistent with pump alarms.A scheduled refill was missed and they never had the pump filled since implant on (b)(6) 2017.The patient also reported a return of pain and diarrhea symptoms since (b)(6) 2018, ¿the past few days.¿ the caller was to follow up with a healthcare professional (hcp).The caller moved to a different state and did not have a doctor, a local manufacturer¿s representative was contacted for hcp listings.The patient tried to contact some pain centers on her own, but was unable to find anyone to take her on as a patient.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp) on 2018-jun-09.The most appropriate follow up contact was provided.The cause of the pump alarm was because the pump reservoir was empty.Actions taken to resolve the issue included the patient being seen at the hcp office on (b)(6) 2018 and the pump was interrogated.The medications were ordered and the refill was scheduled for (b)(6) 2018.The cause of the missed refill was not determined.The patient¿s weight was provided.There were no further complications reported/anticipated.

• 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: 7552888
• MDR Text Key: 109516520
• Report Number: 3004209178-2018-12105
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• 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: 06/09/2018
• Date Device Manufactured: 09/11/2017
• 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: 52 YR
• Patient Weight: 48