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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2004, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 28-jul-2006, udi#: (b)(4). Initial reporter occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a company representative regarding a patient receiving morphine (25 mg/ml at 3mg/day) via an implanted pump. The indication for pump use was non-malignant pain/other non-malignant pain. It was reported that the patient began having withdrawal on (b)(6) 2018. The patient was being taken to surgery on monday ((b)(6) 2018). On (b)(6) 2018 the patient reported that they found out that the ¿tube was crossed¿ and because of this, he was not getting the correct dose of morphine. Per the patient, it had taken 5-6 days to figure out what was wrong, but the neurosurgeon fixed it. No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 8709, serial# (b)(4), implanted: (b)(6)2004. Product type catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep). It was reported that the patient may be a twiddler. No further complications were anticipated/reported.

Event Description

Additional information was received from the consumer indicated that the catheters had crossed again on (b)(6) 2018. It was reported that the pump had been moving. No further complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type catheter. 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
• MDR Report Key: 7730928
• MDR Text Key: 115359931
• Report Number: 3004209178-2018-16892
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/30/2018 Patient Sequence Number: 1