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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Shelf Life Exceeded (1567)

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

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: neu_unknown_prog, product type: programmer, physician.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Information was received from a health care professional via a representative regarding a patient in (b)(6) who was receiving an unknown medication via an implantable pump.The patient's concomitant medications were not obtainable.The patient's medical history was reported as none.It was reported that the pump was implanted on (b)(6) 2016 (the use by date of this pump was (b)(6) 2016).Also on (b)(6) 2016, post-operatively, the pump did not want to interrogate and noted that telemetry failed and to try again.They thought that the pump was flipped but when the patient went to theater it was confirmed that the pump did not flip.When the pump was taken out of the body, several attempts were done to interrogate but the pump did not want to.It was unknown if the issue was resolved at the time of the report.There were no patient symptoms reported at this time and the patient's status was noted as alive-no injury.It was unknown if any environmental/external, or patient factors led or contributed to the issue or what further diagnostic testing or troubleshooting occurred.The pump was reported as explanted also on (b)(6) 2016 and being returned.

Manufacturer Narrative

Analysis revealed the implant time elapsed was 197 days which suggested that the implant was sometime in 2015 before the use by date.Testing revealed the pump met specification and no anomalies were found.Device code no longer applies to this event.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

On 2016-06-14 the representative further reported that it was noted that the expiry date was in 2016, but this pump was now reported to have been implanted in (b)(6) of 2015.The pump was replaced and the patient was administered morphine with a concentration of 10mg at 1mg/per day daily dose.The patient was doing well and had pain relief.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5593854
• MDR Text Key: 43196477
• Report Number: 3004209178-2016-07960
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 00064 YR