ASCENDA
Report
- Report Number
- 3007566237-2016-00989
- Event Type
- Injury
- Date Received
- February 24, 2016
- Report Date
- April 18, 2016
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: PUMP. PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4). THE CATHETER ((B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE DEVICE FOUND CORING, TEARING, OR CUTS IN THE SEAL OF THE SUTURELESS CONNECTOR WHICH MET THE LEAK CRITERIA.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING LIORESAL 2000 MCG/ML; 1869 MCG/DAY VIA AN IMPLANTABLE PUMP. THE DATE OF THE EVENT WAS (B)(6) 2015. IT WAS REPORTED THE PATIENT HAD A SUDDEN LOSS OF THERAPY AND HAD BEEN HAVING SUBCLINICAL SEIZURES SINCE (B)(6). THE PATIENT WOULD SLEEP 24-36 HOURS AND WAKE UP INCOHERENT. THE PATIENT FOLLOWED UP WITH A NEUROLOGIST TO RULE OUT ¿OTHER STUFF. ¿ THE PHYSICIAN DID A SPIRAL COMPUTED TOMOGRAPHY DYE STUDY (B)(6) 2016 AND IT ¿LOOKED GOOD¿. AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE LOGS WERE READ AND THE BATTERY WAS DEPLETED . PER THE PUMP LOGS: THE PUMP WAS IN SAFE STATE (B)(6) 2016 18:32, MOTOR STALL RECOVERY OCCURRED (B)(6) 2016 18:32. RESET OCCURRED-LOW BATTERY; PUMP IN SAFE STATE (B)(6) 2016 18:33 PUMP IN SAFE STATE (B)(6) 2016 18:36. MOTOR STALL RECOVERY OCCURRED (B)(6) 2016 18:36. RESET OCCURRED-LOW BATTERY; PUMP IN SAFE STATE (B)(6) 2016 18:37. THE CAUSE OF THE LOW BATTERY RESET; SAFE STATE WAS NOT DETERMINED . THE PUMP AND CATHETER WERE REPLACED (B)(6) 2016. THE CATHETER WAS FOUND ON TOP OF THE PUMP IN SURGERY AND LEAKED CEREBROSPINAL FLUID. THERE WAS NO PATIENT INJURY. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO RECEIVED LIORESAL BACLOFEN (2000MCG/ML, 1900MCG/DAY, LOT# DS0078N05) IN AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND OTHER SPASTICITY. FOLLOWING AN MRI AND CT, THE PUMP LOGS SHOWED "RESET OCCURRED-LOW BATTERY" AND "PUMP IN SAFE STATE" AT 12:02 HOURS. THE MRI OCCURRED AT 10:40 HOURS AND CORRESPONDS WITH THE MOTOR STALL. NO MOTOR STALL RECOVERY WAS NOTED. FOLLOWING THE MRI, THE PATIENT HAD A DYE STUDY/SPIRAL CT. THE PHYSICIAN NOTED THE PUMP REVERTED TO MINIMUM RATE MODE UPON INTERROGATION TO PROGRAM A CATHETER PRIME FOLLOWING SUCCESSFUL CATHETER ACCESS PORT (CAP) ACCESS. THE PUMP WAS REPROGRAMMED TO THE DESIRED DOSE. A DIFFERENT PHYSICIAN READ THE PUMP LOGS FOLLOWING THE MRI AND SPIRAL CT AND DISCOVERED THE LOW BATTERY RESET, SAFE STATE MESSAGES. IT WAS UNKNOWN WHY THE PUMP WENT TO SAFE STATE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING CONCOMITANT MEDICATIONS, PERTINENT MEDICAL HISTORY, RESULTS AND REASON FOR MRI/SPIRAL CT, TROUBLESHOOTING PERFORMED, IF THE CAUSE OF THE ISSUE WAS DETERMINED, IF THE PATIENT EXPERIENCED SYMPTOMS, AND ACTIONS/INTERVENTIONS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112934 | ASCENDA | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00020 YR | Required Intervention |