ASCENDA

Additional Manufacturer Narrative

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: PUMP. PRODUCT ID 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN VIA AN IMPLANTED INFUSION PUMP. SPECIFIC TYPE OF DRUG, LOT#, CONCENTRATION AND DOSE WERE NOT REPORTED. THE PUMP¿S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY. THE PATIENT HAD THE PUMP SINCE (B)(6) 2015 AND REPORTED TO THE HEALTHCARE PROVIDER (HCP) THAT SHE WAS NOT GETTING THE PROPER MEDICATION AND SHE WAS "VERY SPASTIC." THE PATIENT FINALLY REQUESTED A DYE STUDY AND ONE WAS DONE IN (B)(6) 2016. ON (B)(6) 2016, THE PATIENT FOUND OUT "THERE'S A MALFUNCTION¿ AND "THERE'S A LEAK." NO FURTHER DETAILS WERE PROVIDED. THE PATIENT WAS UNABLE TO GET IN FOR SURGERY UNTIL THE END OF (B)(6) AND WONDERED IF SHE¿D BE OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR SPECIFIC DRUG INFORMATION, OTHER MEDICATIONS THAT THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, MEDICAL HISTORY AND CLARIFICATION REGARDING NOT GETTING THE PROPER MEDICATION, TROUBLESHOOTING, CAUSE OF THE INCREASED SPASTICITY AND ACTIONS/INTERVENTIONS TO RESOLVE IT AND OUTCOME.