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); Data Problem (3196)

Patient Problems Edema (1820); Muscle Spasm(s) (1966); Overdose (1988); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Abdominal Distention (2601); No Code Available (3191)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 2018-feb-09, information was received from an healthcare professional (hcp) regarding a patient receiving morphine (25 mg/ml, 2.99 mg/day) via an implantable pump for non-malignant pain.0n (b)(6) 2018, the hcp was not able to establish telemetry in order to interrogate the pump.The hcp was provided with several troubleshooting recommendations and indicated they would try the recommendations and would call back if needed.There were no reported symptoms and no further information provided.Additional information was received from the consumer on 2018-feb-21.It was first reported that the patient has a ¿very low dose of 2.8.¿ it was reported that there was trouble with the pump.The caller did not know if the pump is on recall and the healthcare professional (hcp) isn't aware if the pump is on recall.The caller reported that the pump turned itself off for no ¿particular reason¿ on (b)(6) 2018.The patient did not have an mri or scan.The patient ¿had a pump fill, and probably two weeks later, and they gave him a readout and everything, afterwards he always gets pump filled, does something, goes and does something, and goes back up, and they check it and they give him a readout, so it was working then, and then he started feeling progressively more painful and then we have seen it before, he went into full blown withdrawal.¿ this withdrawal started in 2018.The patient started getting progressively worse in ¿mid-january.¿ when asked about when the patient experienced withdrawal, it was reported that they ¿really noticed it and called her about it on (b)(6) 2018, but the patient was complaining about pain, smells being strong around (b)(6) 2018, and the patient¿s nose was runny.¿ the caller picked the patient up and took him to the emergency room (er) on (b)(6) 2018.Oncology brought down ¿telemetry things they place on it,¿ and they wouldn't read at all, like ¿it wasn't there.¿ they gave the patient a shot of morphine in the butt, a fentanyl patch, and shortly after that the patient ¿felt very, very sick¿ on ¿probably (b)(6) 2018.¿ the patient thought the pump was working again, so he took the fentanyl patch off and he went to see the hcp.The hcp told them they think oncology turned the pump off, and that ¿it has never stopped working.¿ the caller says that the pump ¿spontaneously¿ came back on, ¿maybe on (b)(6) 2018 (later reported as (b)(6) 2018).It was reported that the patient knew this because the patient put an amp over the pump and could hear the pump ¿click,¿ and the patient was also ¿really spastic and hyper.¿ these issues also occurred on (b)(6) 2018.It¿s been ¿about two weeks,¿ and the patient is still experiencing feelings of overdose and withdrawal on (b)(6) 2018.¿the pump may be working one moment, and then not experiencing the next.¿ the caller stated she ¿doesn't know what the pump is doing.¿ the pump has never alarmed.It was also reported that the patient was bloated around the pump, it was ¿like edema right around the pump¿ which occurred ¿probably around christmas.¿ and it was added, ¿it¿s almost like, its adenitis around it, looks like there is a pocket of fluid surrounding it.¿ the role of the manufacturer¿s representative (rep) and patient services (ps) was reviewed.It was asked if the pump was on recall and inquired about the ¿2011 synchromed ii infusion pump battery pack is at risk for pump failure recall, accumulative pump failure after 72 months.¿ it was then reviewed the expectations with a recall, what the fda classifies a recall as, and if there is any recall.It was also reviewed that the hcp is in the best position to evaluate the recall and see if it relates to one of their patient¿s pumps.The caller was redirected to the hcp to get pump checked and inquire about recalls.The caller confirmed that the hcp hasn't been contacted regarding the recall.Ps offered to send physician listings, after reviewing physician locator website disclaimer to get a second opinion and the caller accepted the offer.There was no out of box failure reported and there was no medical/therapy problem related to the small components product.There were no further complications reported/anticipated.***refer to pe(b)(4) (old pump, alarm, leak) for omitted information***.

• 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: 7295920
• MDR Text Key: 100910319
• Report Number: 3004209178-2018-03923
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• Date Device Manufactured: 02/23/2017
• 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): Other
• Patient Age: 57 YR