ACTIVA
Report
- Report Number
- 3004209178-2015-18721
- Event Type
- Injury
- Date Received
- September 25, 2015
- Date of Event
- January 29, 2014
- Report Date
- August 21, 2017
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389S-40, LOT # VA0E7XH, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708640, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0E7XH, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
FOLLOW-UP FROM THE PATIENT REPORTED THAT SHE HAD BEEN HAVING PROBLEMS WITH HER LEFT HAND EVER SINCE SHE GOT THE DEVICE IMPLANTED. SHE WAS EXPERIENCING RIGIDNESS, STIFFNESS, AND CONTRACTURE. SHE MENTIONED HAVING CARPEL TUNNEL AND SHE HAD TO HAVE CARPAL TUNNEL SURGERY IN THE NEXT FEW WEEKS. SHE PLANNED TO SEE A SURGEON ABOUT THIS ON (B)(6) 2016. SHE ALSO MENTIONED HAVING STENOSING TENOSYNOVITIS, WHERE SHE HAD TO HAVE INJECTIONS EVERY THREE MONTHS TO KEEP THE PAIN DOWN. THE PATIENT HAD HAD MULTIPLE REPROGRAMMING SESSIONS, BUT NOTHING SEEM TO BE SOLVING THE LEFT HAND ISSUE. SHE HAD THE SAME ISSUES WITH STIMULATION ON AND OFF.
A FRIEND OF A PATIENT REPORTED THE PATIENT WAS NOT ABLE TO CONTACT A MANUFACTURING REPRESENTATIVE. THEY EXPLAINED THAT THE PATIENT STATED THEY WERE IN SO MUCH PAIN AND THEIR HAND COMPLETELY LOCKED UP. THE PATIENT HAD GREAT RESULTS "WITH IT" WHEN THEY FIRST GOT "IT", BUT THE PAST FEW YEARS HAVE HAD SEVERAL SETBACKS.
ADDITIONAL INFORMATION FROM A PATIENT REPORTED THAT AFTER THE IMPLANT PROCEDURES THEY WERE DOING FAIRLY WELL UNTIL THE DEVICE WAS TURNED ON. SINCE THE DEVICE WAS TURNED ON THEY BEGAN HAVING MOTOR DYSTONIA AND PAIN IN HER LEFT HAND. THE PATIENT NOTED SHE HAS BEEN IN SEVERE PAIN WITH SEVERE DISUSE SINCE 3 WEEK AFTER TURNING THE DEVICE ON. THE PATIENT NOTED SHE HAS HAD MULTIPLE BOTOX INJECTIONS THREE MONTHS APART, THAT DID NOT HELP. THE PATIENT ALSO HAD TWO AXILLARY BLOCKS AND A STELLATE GANGLION BLOCK. THE PATIENT NOTED THE AXILLARY BLOCKS AND STELLATE GANGLION BLOCK HELPED MORE THAN THE BOTOX BUT IT WAS INVASIVE, SHE NEVER HAD COMPLETE RELIEVE OF PAIN. THE PATIENT ADDED THEY HAVE BEEN GOING CONSTANTLY TO PHYSICAL THERAPY AND OCCUPATIONAL THERAPY FOR ONE YEAR, BUT HER HAND IS CONTRACTED. THE PATIENT HAD AN X-RAY DONE IN 2015 WHICH SHOWED HER HAND IS CONTRACTED. THE PATIENT REPORTED THEY HAVE BEEN SUICIDAL SEVERAL TIMES BECAUSE THE PAIN NEVER STOPS. THE PATIENT STATED SHE IS ONLY MAKING DISABILITY WHERE SHE USED TO MAKE MORE AS A NURSE PRACTITIONER. THE PATIENT REPORTED DISABILITY/PERMANENT DAMAGE AS THE OUTCOME OF THE EVENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THEY HAVE HAD TERRIBLE PAIN IN THE PAST SIX MONTHS. THEY HAVE NOT BEEN ABLE TO LEAVE THEIR DEVICE ON FOR MORE THAN THREE DAYS WITHOUT HAVING TO TURN IT OFF AS THEY BECOME MISERABLE.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER THAT REPORTED THEY WERE STILL HAVING A LOT OF TROUBLE WITH THEIR HAND. THE PROBLEMS HAD NOT STARTED WITH THE HAND UNTIL THEY TURNED THE DEEP BRAIN STIMULATOR ON. THEY HAD TRIED TURNING IT OFF. THIS HAD BEEN GOING ON FOR A YEAR AND A HALF.
A CONSUMER REPORTED THEY HAD EARLY ONSET PARKINSON'S DISEASE AND THEIR TREMOR, GAIT, AND SPEECH DIFFICULTIES HAD IMPROVED. THE PATIENT HAD LEFT SIDED TREMOR AND CONTRACTURES, DYSTONIA, CHRONIC PAIN, AND DISUSE OF THEIR LEFT HAND. THE SYMPTOMS STARTED IN (B)(6) 2014 AFTER DEEP BRAIN STIMULATION (DBS) WAS TURNED ON. THE PATIENT WAS CURRENTLY SEEING A CHRONIC PAIN MANAGEMENT HEALTH CARE PROVIDER (HCP) FOR LEFT HAND POSTURING, CONTRACTURES, AND RIGIDITY THAT WAS THOUGHT TO BE CRPS. A BONE SCAN WAS DONE IN (B)(6) 2014. BOTOX AND STEROID INJECTIONS HAD FAILED AND THE PATIENT'S PAIN WAS UNABLE TO BE MANAGED. REEQUIP HAD CAUSED SIDE EFFECTS OF COMPULSION AND BOTOX HAD NOT RELIEVED THE PATIENT'S SYMPTOMS. THE PATIENT FELT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING MISMANAGED AND THEY WANTED TO SEE A DIFFERENT HCP. THE PATIENT STATED THEY WERE A DISABLED NURSE PRACTITIONER THAT WANTED TO RETURN TO WORK. IN (B)(6) 2015 THE PATIENT HAD 2 AXILLARY NERVE BLOCKS. THE FIRST ONE WORKED WELL FOR 24 HOURS AND THE SECOND ONE LASTED LESS THAN 24 HOURS. THE PATIENT'S MEDICAL HISTORY INCLUDED THE FOLLOWING TESTS. A THREE PHASE BONE SCAN WAS DONE OF THE PATIENT'S HAND. BLOOD FLOW IMAGES SHOWED INCREASED FLOW IN THE LEFT HAND, BLOOD POOL IMAGES SHOWED INCREASED UPTAKE IN THE SOFT TISSUES OF THE HAND, AND RELATED IMAGES SHOWED MINIMAL INCREASE IN UPTAKE WITHIN THE LEFT WRIST AND DIGITS. THE FINDINGS WERE SUGGESTIVE OF REFLEX SYMPATHETIC DYSTROPHY OF THE LEFT HAND. A ATC SPECT SCAN WAS DONE ON (B)(6) 2011 AND AN ABNORMAL DATSCAN BRAIN SPECT BILATERALLY WAS SUGGESTIVE OF PARKINSONIAN SYNDROME AND CLINICAL CORRELATION WAS RECOMMENDED. A COMPLETE MRI OF THE PATIENT'S BRAIN WAS DONE ON (B)(6) 2011. THE MRI FOUND THE VENTRICLES, BASAL CISTERNS AND SULCI WERE NORMAL IN SIZE, SHAPE, AND CONFIGURATION, THERE WAS NO MASS OR SHIFT OF THE MIDLINE, NO ABNORMAL SIGNAL OR ENHANCEMENT INVOLVING THE BRAIN PARENCHYMA, AND GRAY-WHITE MATTER DIFFERENTIATION WAS NORMAL. THERE WERE NO REGIONS OF RESTRICTED DIFFUSION TO SUGGEST AN ACUTE INFARCT, THE BRAINSTEM AND CEREBELLUM WERE UNREMARKABLE IN APPEARANCE, CEREBELLAR TONSILS WERE NORMAL IN POSITION BILATERALLY, AND NO ENHANCING CEREBELLOPONTINE ANGLE MASS WAS IDENTIFIED. THERE WERE NO ACUTE INTRACRANIAL ABNORMALITIES. A COMPLETE MRI OF THE C-SPINE WAS DONE ON (B)(6) 2011. THERE WAS SOME STRAIGHTENING OF THE CERVICAL SPINE WITH MINIMAL REVERSAL OF CERVICAL LORDOSIS AT C3/C4. THERE WAS NO ABNORMAL SUBLUXATION OF THE VERTEBRAL BODIES AND THE SPINAL CORD WAS NORMAL IN SIGNAL. THERE WAS NO EVIDENCE OF ACUTE FRACTURE OR MARROW INFILTRATING PROCESS. THERE WAS MILD INTERVERTEBRAL DISC SPACE NARROWING AT MULTIPLE LEVELS AND MILD LEVOCURAVTURE OF THE CERVICAL SPINE. THERE WERE MULTILEVEL DEGENERATIVE CHANGES OF THE CERVICAL SPINE WITH POSTERIOR DISC/OSTEOPHYTE COMPLEXES AT C3/C4, C4/C5, AND C5/C6 RESULTING IN MILD CENTRAL CANAL NARROWING WHICH WAS MOST PRONOUNCED AT C3/C4. THERE WAS MINIMAL DEFORMATION OF THE VENTRAL ASPECT OF THE SPINAL CORD AT C3/C4 AND C5/C6. THERE WAS MINIMAL FORAMINAL NARROWING ON THE RIGHT AT C3/C4 AND C4/C5 SECONDARY TO FACET AND UNCOVERTEBRAL HYPERTROPHY. STRAIGHTENING OF THE CERVICAL SPINE WITH MINIMAL REVERSAL OF CERVICAL LORDOSIS MAY BE RELATED TO MUSCLE SPASM OR PATIENT POSITIONING. A CT SCAN OF THE PATIENT'S HEAD WAS DONE ON (B)(6) 2015. THE CT SCAN FOUND NO SIGNIFICANT ACUTE INTRACRANIAL HEMORRHAGE, THE MIDLINE HAD NOT SHIFTED, AND THERE WAS NO SIGNIFICANT ATROPHY OR MICROVASCULAR DISEASE. NO ABNORMAL LESIONS WERE IDENTIFIED, CEREBRAL VESSELS APPEARED NORMAL, THE VENTRICLES WERE NOT ENLARGED, THERE WAS NO APPARENT ENCEPHALOMALACIA OR OTHER SIGNIFICANT PROCESS TO SUGGEST PREVIOUS INFARCTION, AND THERE WAS VERY MINIMAL RHINOSINUSITIS. AN X-RAY DONE ON (B)(6) 2015 SHOWED BONE DENSITY WAS ADEQUATE, JOINT SPACES WERE WITHOUT SIGNIFICANT ARTHRITIS, THERE WAS SLIGHT NARROWING OF THE RADIOCARPAL JOINT, AND PARTIAL FLEXION CONTRACTURE OF THE THIRD AND FOURTH METACARPAL PHALANGEAL JOINTS, AND DISTAL INTERPHALANGEAL JOINT OF THE THUMB. THE PATIENT'S INDICATION FOR USE IS MOVEMENT DISORDERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 634398 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R |