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); Unstable (1667)

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

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

References the main component of the device system; the other relevant components include:product id 8835, serial# (b)(4), product type programmer, patient.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient who was receiving dilaudid (hydromorphone) and bupivacaine at unknown concentrations and doses for malignant pain and cancer pain.The patient reported they were experiencing difficulty when activating their personal therapy manager (ptm).They reportedthat the pump and ptm do not connect.An examination was performed on (b)(6) 2016, revealing that the pump was inverted, which could be the source of the difficulty.The device diagnosis was pump inversion.The pump was repositioned on (b)(6) 2017.The pump site was moved from low ¿rlq¿ to upper ¿rlq.¿ the event was related to the device/therapy.The event was not related to the implant procedure.The event resolved without sequelae on (b)(6) 2017.There were no reported symptoms.

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study indicated the outcome was resolved without sequelae on (b)(6) 2017.The pump was delivering dilaudid (1.0 mg/ml at 0.1999 mg/day) and bupivacaine (30.0 mg/ml at 5.996 mg/day).

Event Description

Additional information received from a healthcare provider via a clinical study reported examination revealed that the pump had become dislodged from its sutures and was flipping with the pocket.It was noted the patient's baseline weight was (b)(6).

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6311722
• MDR Text Key: 66816212
• Report Number: 3004209178-2017-02814
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• 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: 05/25/2017
• Date Device Manufactured: 05/04/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 113