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

Model Number 8637-20

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Muscle Weakness (1967); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 12/31/2019

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 morphine via an implanted pump.When asked the dose and concentration, the patient stated, ¿i think it has something like 250 every 3 hours and 4.79 on a constant".The patient was calling because he wanted to have his pump removed.He stated that it was his fourth pump and it was not working for him and then clarified that he was not getting any relief and he was considering having it removed.Per the patient, the pump ¿tore loose¿ clarifying that it was not anchored anymore.He stated that due to having so many surgeries, his stomach muscles were so weak that he could barely raise his voice and could not shout.His legs were much weaker and were causing him pain and he was not able to work on his arms.He also stated that due to having so many surgeries he had not been able to perform sex with his wife.

• 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: 10771434
• MDR Text Key: 214147577
• Report Number: 3004209178-2020-19105
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Date Device Manufactured: 12/16/2019
• 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: 53 YR