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 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Information received from an internal manufacturer source indicated the pump failed telemetry and was sent for analysis.The pump was a backup and sent to the distribution center because it was not used.There was no allegation from the field.There was no indication of patient interaction.The pump was returned unopened in the box.No further information was provided.

Manufacturer Narrative

Analysis found foreign material inside the pump.The analysis lab was unable to achieve telemetry through the box via a model 8840 clinician programmer or lab view.No trauma to the box itself was observed by the analysis lab, and no alarms sounded.Upon opening the box and performing several tests in an attempt at telemetry, it was determined that the pump had a complete loss of power.X-ray analysis was performed and no anomalies that could cause a hard short and total battery depletion were observed.The pump was then opened and foreign material was observed on the (b)(4), now mobile.After opening the pump and removing the foreign material, (b)(4) was achieved.(b)(4) showed a hard short (por) had occurred and showed rising voltages in the minute history.The foreign material is extremely soft, colored with shades of tan, and contained white and blue fibers.The foreign material is consistent with a mixture of (b)(4).It is likely that the foreign material is biological in nature, and has been exposed to some sort of detergent, surfactant, or cosmetic.It is also possible that the foreign material is an (b)(4).

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.

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: 5739914
• MDR Text Key: 47895457
• Report Number: 3004209178-2016-12654
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2016

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: 10/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/04/2016
• Supplement Dates FDA Received: 08/25/2016; 10/06/2016; 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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