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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving morphine, baclofen, and one unknown drug (unknown con centration and dose) via an implantable pump.Indication for use was non-malignant pain.The date of the event was unknown.It was reported the pump battery failed.The healthcare provider had been increasing the drug.The pump did not last the full amount of time for normal battery depletion.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received via saol.It was reported the patient is caucasian and was(b)(6) at the time of the event onset.On (b)(6)2015, the patient started treatment with compounded baclofen 425 ¿g/ml at an unknown dose.Concomitant products included alpha-lipoic acid, vitamin b12, biotin, vitamin c, coq-10, vitamin b2, vitamin d3, cytomel (liothyronine sodium), flonase (fluticasonepropionate), levoxyl (levothyroxine sodium), magnesium, maxalt (rizatriptan benzoate), milk thistle, nifedipine, nystatin/triamcinolone,ondansetron, pataday (olopatadine hydrochloride), promethazine, promethegan (promethazine), relistor (methylnaltrexone bromide),senokot, skelaxin (metaxalone), trazadone, vivelle-dot (estradiol), voltaren (diclofenac sodium), "vsl #3," wellbutrin (bupropionhydrochloride) and zenpep (pancrelipase).Medical history included non-malignant pain, chronic pain (20 years), nerve pain following laminectomy (2011).On an unreported date, she started treatment with hydromorphone 1000 ¿g/ml at 132.3 ¿g/day.

• 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: 7267644
• MDR Text Key: 100056094
• Report Number: 3004209178-2018-03220
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• Date Device Manufactured: 05/16/2014
• 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