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

Model Number 8637-40

Device Problem Unstable (1667)

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

Event Date 06/23/2018

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 via a device manufacturer representative regarding a patient receiving an unknown drug via an implantable infusion pump.The indication for use was non-malignant pain and failed back surgery syndrome.It was reported that the patient was unexpectedly locked out from receiving a bolus.The personal therapy manager (ptm) technical report was reviewed and the lockout parameters were described as: l/o 4 hours, dri 6/24 hours max 5.It was reported that the caller had 3 occurences of 88 and 89 codes being displayed at the same date and time.Troubleshooting was performed and resolved the issue.No symptoms were reported.No further complications have been reported as a result of this event.Additional information was received from a patient on (b)(6) 21018.It was reported that ¿her pump moved around and not in the correct spot.Her doctor made an x-ray to correct placement, therefore antenna should work better now.¿ there were no further complications reported/anticipated.

Manufacturer Narrative

Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report had malfunctioned.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that the patient was receiving her boluses upon request however, the patient needed an antenna because the patient was unable to determine if the bolus was received on her personal therapy manager (ptm) device due to a communication issue.It was reported that the patient was provided an antenna.It was stated that the hcp did not indicated that there was any pump movement.No further complications have been reported as a result of this event.Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

• 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: 7664529
• MDR Text Key: 113257420
• Report Number: 3004209178-2018-15084
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/17/2018
• Date Device Manufactured: 08/01/2014
• 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: 58 YR