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

Model Number 8637-40

Device Problem Torn Material (3024)

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

Event Type  Injury  

Event Description

It was reported that the patient was having surgery to suture down her pump because it kept flipping.The pump flipping did not cause any patient symptoms.The pump was flipping due to movement in the pocket; the movement was attributed to broken suture loops.The patient was doing well, was receiving effective therapy, and getting good pain relief.The patient status at the time of the report was alive with no injury.The pump system was being used to infuse fentanyl and bupivacaine.

Manufacturer Narrative

Concomitant products: product id: 8709, lot# l78422, implanted: (b)(6) 2000, product type: catheter.Product id: 8578, serial# (b)(4), implanted: (b)(6) 2014, product type: accessory.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4745595
• MDR Text Key: 5771260
• Report Number: 3004209178-2015-08370
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2015
• Date Device Manufactured: 11/12/2014
• 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: 00061 YR