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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

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 patient and a manufacturer¿s representative (rep) regarding an implantable drug infusion device.The drug being delivered was not reported.The reason for use was non-malignant pain and chronic low back pain.It was reported that the handset screen displays a communication message of ¿no pump found.¿ the patient had a mammogram this morning ((b)(6) 2019) and when she got home she attempted to use her ptm and communicator and she keeps getting ¿no pump found.¿ they discussed basic use and to reboot the handset.Caller states the patient is not with him now.They also discussed having the patient contact patient services (ps) for troubleshooting.There were no symptoms reported.Additional information was received from the patient on (b)(6) 2019.The patient was calling back with equipment to troubleshoot 'no pump found.¿ ps had the patient was to power down the handset/communicator, the patient ensured communicator/handset weren't plugged into wall and were sufficiently charged, ensured that the communicator was directly over pump, the patient was not around electromagnetic interference (emi) and was in the bathroom while troubleshooting.Ps also had the patient click switch communicator once to try that option but this didn't resolve issue.The patient was still getting pump not found.They did note that she had a band over the pump from having it implanted but that she could tell communicator was directly over pump, and she had previously been able to connect with the pump prior to this issue.Ps warm transferred the patient to the repair department for a replacement communicator (ps consulted with technical services (ts) department and they reviewed that it was hard to tell which component would be causing the issue and reviewed repair can try replacing communicator first).Additional information was received from the rep on (b)(6) 2019.They reported with the new communicator she could not establish connection to the pump.Ts reviewed considerations and was not able to connect the pump to ptm.Ts did have the caller try to connect the tablet to pump and was unable.The caller did try with the 8840 and still was not able to connect to the pump.The caller stated everything was working fine until the patient had a mammogram.Ts reviewed typically that would not interact with the pump.Ts gave consideration to see if the pump was flipped and to do a lateral view of the pump to see.The caller stated she will call back if it isn¿t flipped (note: caller believes most likely the pump was sutured.) 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: 8823439
• MDR Text Key: 152104678
• Report Number: 3004209178-2019-14187
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Date Device Manufactured: 02/19/2019
• 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: 51 YR