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

Model Number	8637-20
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient receiving morphine via an implanted pump.The patient was calling to review recall information regarding the pump.Per the patient, she felt that the pump was intermittently not working.She stated that she found online that her pump¿s serial number was not included in a recall, but she wanted to know some of the symptoms that one might experience.When asked when the issue began, the patient stated, ¿it has been quite a while and it is intermittent¿.She stated that she felt that she was not getting the medication ¿although the biggest amount of medication difference was like, ah i can't remember, point oh i don't remember it only holds 20 so i guess it was like 5".She stated, "my pain is so severe it feels like its not working".The patient then stated, "maybe it is, and this is just my pain".She stated the feeling was intermittent and it got really bad and then it got better ¿not better, but ya know better".Per the patient, the pump was not alarming.She stated that her pump alarmed before when she had an mri and the pump would alarm when she got to 2 ml of morphine left in the pump.The patient also stated that sometimes when she tries to bolus ¿the printout shows she pressed the button 2x which cancelled the bolus request and when it does funny thing she sends a picture of the screen to her home nurse¿.The ptm programming was ¿.0315 mg bolus,.6174 per day, 4x day, 1x 180m, 4x24hr, bolus duration 1 min, 4.4mg,.6714 mg, 0.0280 mg/hour, max daily dose.7955 mg/day¿.

• Brand Name: SYNCHROMED II
• Common Device Name: 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: 11045728
• Report Number: 3004209178-2020-22282
• Device Sequence Number: 16460048
• Product Code: LKK
• UDI-Device Identifier: 00643169984219
• UDI-Public: 00643169984219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR