SYNCHROMED II
Report
- Report Number
- 3004209178-2017-10255
- Event Type
- Injury
- Date Received
- May 15, 2017
- Date of Event
- April 19, 2017
- Report Date
- July 18, 2017
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- UDI-DI
- 00613994779229
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1579-2013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
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.
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
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.
THE MAIN COMPONENT OF THE DEVICE SYSTEM; OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2017, PRODUCT TYPE CATHETER. (B)(4).
ANALYSIS OF THE PUMP IDENTIFIED A FEEDTHROUGH ANOMALY THAT CAUSED SHORTING ACROSS THE INSULATOR, AND A GEAR TRAIN ANOMALY DUE TO CORROSION AND WEAR, AND A MOTOR STALL DUE TO SHAFT-BEARING. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY; IT WAS INCOMPLETE/ RETURNED IN SEGMENTS AND WAS FOUND TO BE ACCEPTABLE DURING TESTING. RECALL: CORRECTION: THE PREVIOUSLY REPORTED CORRECTION NUMBER Z-0497-2013 DOES NOT APPLY AS THE PUMP WAS USED TO INFUSE AN APPROVED DRUG. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) ON (B)(6) 2017. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE MOTOR STALLS. THE ACTIONS/INTERVENTIONS TAKEN WERE THE PATIENT WAS REFERRED TO A PEDIATRIC NEUROSURGEON FOR IMMEDIATE PUMP REPLACEMENT. THE PATIENT¿S WEIGHT WAS UNKNOWN. THE MOTOR STALLS HAD NOT BEEN RESOLVED AS THEY WERE WAITING ON PUMP REPLACEMENT. THE REMAINING PUMP VOLUME WAS 11.5 ML ACCORDING TO THE PUMP PROGRAMMER. GABLOFEN DOSING WAS LEFT UNCHANGED AT A SIMPLE CONTINUOUS INFUSION AT 469.8 MCG/DAY. THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS AT 34 MONTHS. THE PUMP EVENT LOGS SHOWED A MOTOR STALL ON (B)(6) 2017 AT 01:14, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 01:38, MOTOR STALL ON (B)(6) 2017 AT 06:09, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 06:34, MOTOR STALL ON (B)(6) 2017 AT 03:56, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 04:23, MOTOR STALL ON (B)(6) 2017 AT 15:02 AND 19:17, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 15:27 AND 19:58, MOTOR STALL ON (B)(6) 2017 AT 01:50, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 02:44, MOTOR STALL ON (B)(6) 2017 AT 01:09, 06:01, 22:44, MOTOR STALL RECOVERY ON (B)(6) 2017 AT 01:55, 06:28, 23:31, MOTOR STALL ON (B)(6) 2017 AT 13:56, AND MOTOR STALL RECOVERY ON (B)(6) 2017 AT 14:52. PROGRESS NOTES WERE PROVIDED FROM THE APPOINTMENT ON (B)(6) 2017. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. A BACLOFEN PUMP FAILURE WAS NOTED AS WELL AS THE PRESENCE OF AN INTRATHECAL BACLOFEN PUMP AND CONGENITAL QUADRIPLEGIA. THE PATIENT WAS FELT TO BE DOING GOOD AT THE PRESENT TIME. THE HCP REFERRED THE PATIENT TO NEUROSURGERY FOR INTRATHECAL BACLOFEN PUMP REPLACEMENT. THE PATIENT WOULD FOLLOW-UP AFTER 4-6 WEEKS AFTER THE PUMP WAS CHANGED. AT BIRTH, THE PATIENT WAS AS WHITE AS A SHEET AND NOT BREATHING. SHE WAS NOTED TO HAVE APGARS OF 0 AND 3. THE PATIENT SPENT 24 TO 26 DAYS IN THE NURSERY INTENSIVE CARE UNIT. THE PATIENT HAD 4 BLOOD TRANSFUSIONS DURING THAT TIME. THE PATIENT WAS ON A VENTILATOR FOR ABOUT 1 WEEK. SHORTLY AFTER BIRTH, SHE WAS HAVING CONTINUOUS SEIZURES FOR AT LEAST 48 HOURS UNTIL PHENOBARBITAL WAS ADJUSTED APPROPRIATELY. THE PATIENT HAD MULTIPLE TESTS DONE AND NEURO-IMAGING WITH MRI, CT SCANS, AND ULTRASOUND, ALL OF WHICH WERE UNREMARKABLE. THE PATIENT WAS DIAGNOSED WITH MICROCEPHALY AND MALDEVELOPMENT OF THE CEREBRUM AND CEREBELLUM, FELT DUE TO ANOXIC-HYPOXIC BRAIN INJURY. THE PATIENT HAD EARLY CHILDHOOD INTERVENTION AND WAS SEEN BY A PHYSIATRIST FOR CONGENITAL SPASTIC QUADRIPLEGIA. THE PATIENT WAS REFERRED TO A DIFFERENT HOSPITAL FOR SPASTIC QUADRIPLEGIA AND ANOTHER HOSPITAL FOR SEIZURES. THE PATIENT WAS DIAGNOSED AS HAVING CORTICAL VISUAL IMPAIRMENT. THE PATIENT NEVER LEARNED TO CRAWL OR WALK. IN 2011, THE PATIENT HAD RIGHT HIP SURGERY AND IN 2012 HAD RIGHT HIP RECONSTRUCTION AND LEFT HIP SURGERY FOR COMFORT. SINCE HER SURGERIES, THE PATIENT HAD NEVER BEEN ABLE TO STAND WELL. THE PATIENT WAS TREATED WITH ORAL SPASTICITY MANAGEMENT UTILIZING VALIUM, BOTOX INJECTIONS, AND BACLOFEN PUMP PLACEMENT INITIALLY IN 2009. THE PATIENT¿S PUMP ALARMED ON (B)(6) 2017. ON (B)(6) 2013, A MRI OF THE BRAIN WAS PERFORMED. IT SHOWED EXTENSIVE WIDESPREAD CHANGES OF CHRONIC CYSTIC INSENSIBLE MALAYSIA INVOLVING THE CEREBRAL HEMISPHERES MAINLY ALONG THE SUPERIOR ASPECTS OF THE CEREBRAL HEMISPHERES WITH SOME EXTENSION INTO THE PARIETAL AND OCCIPITAL REGION PARASAGITTALLY. THERE WERE ASSOCIATED GLIAL CYSTS IN THE WHITE MATTER AND ENLARGEMENT OF THE LATERAL VENTRICLES. THERE WAS RELATIVE SPARING OF THE CEREBELLUM, BRAINSTEM, BASAL GANGLIA, ANTERIOR TEMPORAL AND LEFT FRONTAL LOBE. THE PATIENT SHOWED MICROCEPHALY- AT AND THEIR MUCOSAL MEMBRANES WERE MOIST. THE PATIENT HAD A G-TUBE, HAD MILD THORACOLUMBAR SCOLIOSIS, WAS NONAMBULATORY, AND WAS NONVERBAL. THE PATIENT DID NOT TRACK VISUALLY AND HAD CONSTANT ROVING EYES.
(B)(4) (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML GABLOFEN AT A DOSE OF 469.8 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION AND THE PATIENT DID NOT RECENTLY HAVE AN MRI. THE PUMP STATUS AND/OR EVENT LOG REPORT SHOWED MULTIPLE MOTOR STALLS AND RECOVERIES. STALLS OCCURRED ON (B)(6) 2017. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE ON 2017-MAY-19. THE PATIENT'S PUMP AND A PORTION OF THE CATHETER WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PROVIDED PUMP LOGS THAT WERE READ ON (B)(6) 2017 SHOW A MOTOR STALL RECOVERY ON (B)(6) 2017 AT 02:37; ON (B)(6) 2017, THERE WERE MOTOR STALLS AT 01:02, AND 05:54, WITH MOTOR STALL RECOVERIES AT 01:48, 06:21, AND 23:24; A MOTOR STALL ON (B)(6) 2017 AT 13:49, FOLLOWED BY A MOTOR STALL RECOVERY AT 14:45; ON (B)(6) 2017, THERE WERE MOTOR STALLS AT 00:40, 20:01 AND 22:07, WITH MOTOR STALL RECOVERIES AT 01:34, 20:57, AND 22:46; ON (B)(6) 2017, MOTOR STALLS OCCURRED AT 06:51 AND 08:57, WITH MOTOR STALL RECOVERIES AT 07:47 AND 09:36; ON (B)(6) 2017, THERE WAS A MOTOR STALL AT 04:21 FOLLOWED BY A RECOVERY AT 04:56; AND ON (B)(6) 2017, THERE WAS MOTOR STALL AT 02:03 FOLLOWED BY A RECOVERY AT 03:27.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE ON (B)(6) 2017. THE PUMP WAS REPLACED ON (B)(6) 2017 AS THE PUMP HAD NOT RECOVERED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE ON (B)(4) 2017. IT WAS REPORTED THAT A CATHETER EVENT WAS CONFIRMED AS THE CATHETER CONNECTOR WAS FOUND TO BE BROKEN AT THE PUMP REPLACEMENT ON (B)(6) 2017. A NEW PUMP SEGMENT KIT WITH A SUTURELESS CONNECTOR AND CATHETER CONNECTOR WAS USED. THE NEW CATHETER VOLUME WAS CONFIRMED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348015 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 | 00613994779229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention |