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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Ambulation Difficulties (2544)

Event Date 04/01/2020

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 receiving baclofen via an implanted pump.It was reported that the patient thought his pump was not working because there was a recall on his pump.He stated that since the beginning of this year (b)(6) 2020 the pump stopped working.His symptoms changed and he knew he wasn¿t getting the medicine.Then 1.5 days later (also stated as 24-30 hours later) he went back to being fine/normal again.He stated that he wasn¿t sure if the pump had stopped or if there had been a ¿kink in the line or something¿.Then it was time for a pump refill about a month later and he told his doctor what was going on.The doctor removed the medication and refilled the pump, and the doctor rechecked the pump and nothing showed any kind of trouble.The patient stated that he told the doctor the pump never alarmed and he knew what that was like ¿because they had run the pump dry and run the pump on saline at one point¿ so he knew what symptoms he had when he was not getting the baclofen.Per the patient, ¿that has happened to me at least twice¿.He stated that he knew he was not getting any medication because he was walking flatfooted and had pain back in his hip area (complete hip area).He also had leg spasticity.Per the patient, they had not done a catheter dye study on his pump.The patient also stated that the pump had stalled twice and now it was working.It was reviewed with the patient that the doctor could pull the records from the pump which would show if the pump stalled.He then stated that the doctor did pull the pump records and the pump did not show the pump stalled.The pump records didn¿t show any sort of trouble.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11002185
• MDR Text Key: 221494487
• Report Number: 3004209178-2020-21745
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/14/2020
• Date Device Manufactured: 02/14/2019
• 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: 60 YR