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

Model Number 8637-20

Device Problem Failure to Interrogate (1332)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer¿s representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use.It was reported that the hcp was with a patient and when they attempted telemetry, after a few seconds they would get invalid telemetry.Upon replacement of the telemetry head, the issue still occurred.The hcp had 2 n¿visions; they tried telemetry with both with no luck.The pump was below the surface of the skin and they could feel the membrane to the reservoir, so they knew the pump had not flipped.There were no reported symptoms.

Manufacturer Narrative

The manufacturing site id was previously reported as (b)(4).Additional information indicates the correct manufacturing site id is (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that they did not try to establish telemetry in another room to see if that would have resolved the issue.They did report that they had three other patients that day that had no problems.At the last refill date, they also had interrogation problems but when the ¿patient came in to a bed and the pump was straight when the interrogation was good.¿ it was noted that this time it did not work.It was also discussed to try interrogating without putting a checkmark in the ¿logs¿ and ¿notes¿ box to see if that would reduce the amount of telemetry time needed.The manufacturer representative reported that maybe it could help with no check marks.It was reported that the implant date of the pump was (b)(6) 2014.It was noted that there was no harm or injury to the patient and that the patient status was good.The patient¿s medical history included sclerose.

Event Description

Additional information received indicated the manufacturer representative spoke with the hcp who took over the patient from the hospital.The hcp reported better telemetry without checking "logs" and "notes." the refill was performed and the pump was updated.The hcp will wait for the next refill to see if the issue persists.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos,pr MN 00777 1200
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6249738
• MDR Text Key: 64769781
• Report Number: 3007566237-2017-00129
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2017

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: 06/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/01/2017; 02/01/2017
• Supplement Dates FDA Received: 01/18/2017; 02/06/2017; 09/28/2017; 09/29/2017
• Date Device Manufactured: 12/21/2013
• 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