SOLETRA
Report
- Report Number
- 3004209178-2012-08576
- Event Type
- Injury
- Date Received
- September 26, 2012
- Report Date
- August 29, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0349246V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # J0349246V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD.
DUE TO THE MERGING OF EVENTS, PATIENT CODE (B)(4) WAS ADDED. CONCLUSION CODE WAS REMOVED AND RE-ADDED.
(B)(4).
(B)(4).
IT WAS REPORTED THAT THERE WAS LOSS OF COGNITIVE FUNCTION AFTER AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS "POSSIBLE ALZHEIMER'S." IT WAS STATED THAT BEFORE THE INS WAS INSTALLED IN (B)(6) 2004, THE PATIENT'S COGNITION WAS SUPERIOR, AND SINCE THE DEVICE WAS IMPLANTED, HIS CONDITION HAS GOTTEN WORSE. IT WAS STATED "AT THIS TIME THE PATIENT CAN'T REMEMBER HIS ADDRESS." THE DEVICE WAS REPROGRAMMED, BUT NOTHING SEEMED TO HELP WITH THE SYMPTOMS. THE PATIENT HAD A COMPUTED TOMOGRAPHY SCAN (CT) IN 2008 AND THE HCP HAD STATED "EVERYTHING LOOKED FINE." NOW HCP IS FINDING SOMETHING DIFFERENT AND IS CONCERNED IT MAY BE ALZHEIMER'S. PATIENT STATUS IS UNDETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THIS PATIENT HAD TWO DEVICES AND IT WAS UNKNOWN WHICH DEVICE THE EVENT PERTAINS TO, SO A REPORT HAS BEEN FILED ON BOTH. REFER TO MANUFACTURING REPORT NUMBER 3004209178-2012-08575.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER SPOKE WITH THE DOCTOR ON THE DAY PRIOR TO REPORT BECAUSE THE PATIENT HAS HAD SOME COGNITION ISSUES AND HAD BEEN HAVING THEM SINCE 2004 WHEN THE PATIENT GOT IMPLANTED. IT WAS NOTED THAT THE DOCTOR ADVISED TURNING THE STIMULATION OFF AND IF THE DYSTONIA SYMPTOMS WORSENED THEN TURN IT BACK ON. IT WAS NOTED THAT THE DOCTOR STATED IF THE SYMPTOMS DIDN¿T WORSEN THEN TO LEAVE THE STIMULATOR OFF TO SEE IF THE COGNITION ISSUES REDUCED BECAUSE THE DEEP BRAIN STIMULATION (DBS) MIGHT BE A CONTRIBUTOR TO THE COGNITION ISSUES THAT THE PATIENT IS EXPERIENCING. IT WAS NOTED THAT THE PATIENT HAD HAD NEUROPSYCH EVALUATIONS. IT WAS NOTED THAT PRIOR TO IMPLANT THE PATIENT HAD SUPERIOR RANGE COGNITION ON NEUROPSYCH AND SINCE THEN IT HAD BEEN A STEADY DECLINE ON NEUROPSYCH EVALUATIONS. IT WAS NOTED THAT THE PATIENT WAS SEEN BECAUSE OF COGNITION ISSUES AND NOT A REGULAR SCHEDULED APPOINTMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD DEVELOPED A GRADUALLY PROGRESSIVE NEURODEGENERATIVE ILLNESS COMBINED WITH ALZHEIMER'S DISEASE AND FRONTAL LOBE DEGENERATION WITH CEREBRAL ATROPHY ON BRAIN MRI. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD DEMENTIA THAT HAD DEVELOPED AFTER THE IMPLANT. THE MRI DETERMINED THE PATIENT HAD SHRINKAGE, VASCULAR DEMENTIA, AND ALZHEIMER'S DISEASE. PET SCAN WAS ALSO PLANNED. PATIENT'S CURRENT STATUS WAS NOT GOOD AT THIS POINT. THE PATIENT COULD NOT DRIVE AND HAD TO HAVE HIS MEDICATION MONITORED. HE ALSO COULD NOT BE ALONE. IT WAS STATED THAT PATIENT'S AMPLITUDE AND PULSEWIDTH SETTINGS WERE SO HIGH THAT HE WAS HAVING IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED EVERY YEAR. IT WAS BELIEVED THE DEVICES WERE ON BUT NOT REALLY HIGH. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPING ALZHEIMER'S DISEASE WAS BELIEVED TO BE DEVICE RELATED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IMAGING DONE ON (B)(6) 2010 FOUND PARENCHYMAL VOLUME LOSS. WITH DBS STIM UNCHANGED FROM PREVIOUS, AN MRI IN 2012 FOUND NON-SPECIFIC WHITE MATTER CHANGE. SYMPTOMS INCLUDED DEMENTIA AND DEPRESSION. THE PATIENT HAD PROGRESSIVE DEMENTIA OVER MANY YEARS, WORSE SINCE 2010. FOLLOWING IMPLANT THE PATIENT'S WIFE FELT THE PATIENT HAD REDUCED MEMORY. PRIOR TO THIS HE HAD TROUBLE EXPRESSING HIMSELF WHILE STILL WORKING. THE PATIENT HAD NEUROPSYCHOLOGICAL ASSESSMENTS IN 2010 AND 2011. IT WAS NOTED THE PATIENT'S APPETITE WAS TERRIBLE AND THAT A DRIVING EVALUATION RECOMMENDED NO HIGHWAY DRIVING. THE PATIENT WOULD 'GET WORSE' AS THE DAY GOES ON, FREQUENTLY RESULTING IN INCREASED CONFUSION LATER IN THE DAY. A CT SCAN FROM 2010 SHOWED POSSIBLE ASYMMETRIC ATROPHY SLIGHTLY MORE ON THE LEFT HEMISPHERE THAN THE RIGHT HEMISPHERE. THE PATIENT HAD DYSTONIA WITH THE HEAD TURNED TO THE LEFT PRIMARILY. THE PHYSICIAN PLANNED A COURSE OF INDIVIDUAL SPEECH THERAPY, AND NOTED THE PATIENT MAY BE A CANDIDATE FOR GROUP APHASIA THERAPY AS WELL. OTHER POSSIBILITY OF DEMENTIA ASSOCIATED WITH CERVICAL DYSTONIA WAS UNLIKELY. IT WAS NOTED THAT THE POSSIBILITY OF FRONTOTEMPORAL TYPE DEMENTIA PRESENTING WITH LANGUAGE DYSFUNCTION AS HIS EARLY ONSET SHOULD BE CONSIDERED. PATIENT OUTCOME WAS NOTED AS SERIOUS INJURY, ONGOING.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT CONTINUED TO HAVE A SIGNIFICANT MENTAL DECLINE SINCE IMPLANT. THEY HAVE SEEN SEVERAL PHYSICIANS AND THE CONSUMER WANTED HER HUSBAND, THE PATIENT, BACK THE WAY HE WAS BEFORE THE SURGERY. THE CONSUMER DID NOT KNOW WHO TO TURN TO AT THIS POINT. REFER TO MANUFACTURING REPORT #3007566237-2015-03210 AS THIS WAS A REPORT SUBMITTED DUE TO THE PATIENT SENDING IN (B)(4). FOLLOW-UP WITH THE CONSUMER DETERMINED THE EVENTS WERE THE SAME AND ANY FURTHER INFORMATION WILL BE SUBMITTED VIA THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MDT PUERTO RICO OPERATIONS CO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Disability |