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 Problems Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

In (b)(6) of 2015, it was determined that the patient¿s pump had broken loose; 2 of the 4 anchors had broken and the pump was twisted.The pump was flipped.Per the patient, it was twisted before he knew something wasn¿t right; he didn¿t realize it was that bad.He made a special appointment besides his refill appointment in (b)(6).The hcp (healthcare professional) suggested that he wear an abdominal binder when he was up and then remove it before he lied down.The pump was uncomfortable on both sides and on top of the pump.The pump was twisted so that the ¿far side closest to the inside of his body and the top side now which is protruding to the top of his skin¿.The patient had an appointment on (b)(6) 2015 for consultation for surgery regarding the pump.The device system was delivering bupivacaine and dilaudid.

Event Description

Additional information reported 2 of the 3 ¿anchors¿ broke free and the pump was ¿basically coming through my skin.¿ the pump was flopping around in his belly.The pump was currently tilted in the pocket.The revision surgery took placed on wednesday ((b)(6) 2015) to re-suture down the pump and reprogram.The hcp was reportedly planning on putting baclofen in the pump.The patient still had concerns with the device or therapy, but was working with the hcp or manufacturer representative.No outcome was reported regarding this event.Additional information could not be obtained at the time of the report.Should additional be received a supplemental report will be filed.

Manufacturer Narrative

Concomitant medical products: product id 8835, serial# (b)(4), product type: programmer, patient.Product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

Additional information was received from a consumer.On (b)(6) 2015, it was reported that the patient had to have the pump repositioned because two of the metal hooks on the outside of the pump broke.On (b)(6) 2015, it had to be "reinserted surgically on side".

• 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: 4751906
• MDR Text Key: 5786318
• Report Number: 3004209178-2015-08535
• 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: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• 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?: No
• Date Manufacturer Received: 08/17/2015
• Date Device Manufactured: 11/07/2014
• 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: 00055 YR