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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Communication or Transmission Problem (2896); Protective Measures Problem (3015); Intermittent Communication Failure (4038)

Patient Problems Sweating (2444); Weight Changes (2607)

Event Date 07/02/2018

Event Type  malfunction  

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.It was reported that the cause of the pump flip was unknown.The patient had recently lost a lot of weight and was caring for her grandson.

Manufacturer Narrative

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

Event Description

Information was received from a patient who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for spinal pain.It was reported that the patient was trying to bond her personal therapy manager (ptm) with her pump, but she was getting a poor communication message on the ptm screen ((b)(6) 2018).Her pump may have flipped or stopped working when she got adjusted at the chiropractor, and went through a metal detector on the same day ((b)(6) 2018).The patient was sweating more because she was unable to get her bolus.Troubleshooting was performed: the patient pushed the selector key to bond the ptm to the pump; she was getting the poor communication message when she did so.The patient was redirected to follow up with her healthcare provider.No further complications were reported.Additional information was received from the healthcare professional.It was reported that the pump was flipped, which caused the poor communication.An x-ray was taken, the pump was flipped manually, and a bolus was able to be given.The poor communication, sweating and bolus issue were resolved.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: 7698860
• MDR Text Key: 114841964
• Report Number: 3004209178-2018-16047
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/28/2018
• 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: 49 YR
• Patient Weight: 100