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

Model Number 8637-40

Device Problems Aspiration Issue (2883); Material Integrity Problem (2978); Torn Material (3024)

Patient Problem Pain (1994)

Event Date 10/10/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 8709sc, serial # (b)(4), implanted: (b)(6) 2007, product type catheter.

Event Description

It was reported that the patient had been experiencing increased pain of the low back for 4-6 weeks so a dye study was performed.It was discovered that the pump flipped fairly readily.The physician attempted to aspirate the catheter and perform a dye study but was unable to aspirate the catheter so the dye study was not able to be completed.The physician suspected a catheter issue; however, the exact catheter issue was unknown at that time.The physician tentatively scheduled the patient for a catheter revision on (b)(6) 2014.During the revision, when the physician opened the pump pocket, it was discovered that the catheter was tightly coiled ¿like a rubber band.¿ the physician unwound the catheter, cut out a section of the catheter, and reconnected it using the existing sutureless connector.The spinal segment in the intrathecal space was left untouched.The pump positioning was due to pump movement which occurred because of broken sutures at the suture loops.Following the revision, the patient was doing well and receiving effective therapy.The device system delivered fentanyl.

Manufacturer Narrative

Concomitant product: product id 8578, serial # (b)(4), implanted: (b)(6) 2014, product type accessory.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that another pump study was performed (b)(6) 2015.On (b)(6) 2015 the healthcare professional's (hcp) nurse had aspirated 26ml of drug from the patient's pump instead of the expected 6ml.The hcp was unable to aspirate the pump so the dye was not pushed.The hcp has not yet decided how he is going to proceed at the time of this report.The reporter noted that the patient had a heart condition and further surgery may therefore not be a possibility.The hcp may instead attempt to manage the patient's increased pain through dosing adjustments.

Manufacturer Narrative

(b)(4).

Event Description

The previously reported issue of volume discrepancy will now be followed in mfg.Report # 3004209178-2015-08138.The issue occurred after the pump flip/revision and was made its own 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 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: 4334263
• MDR Text Key: 12615154
• Report Number: 3004209178-2014-24062
• 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,Followup,Followup,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• 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: 04/29/2015
• Date Device Manufactured: 06/02/2014
• 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: 00075 YR