FDA Adverse Event Injury Summary report: N

DEEP BRAIN STIMULATION LEAD

MDR report key: 989147 · Received January 29, 2008

Report

Report Number
6000153-2008-00455
Event Type
Injury
Date Received
January 29, 2008
Date of Event
November 27, 2007
Report Date
January 3, 2008
Manufacturer
MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code
MHY
PMA / PMN Number
P960009
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE HCP REPORTED THE PATIENT STATUS ONE-DAY POST DBS REVISION; INTERROGATION OF THE LEFT-SIDED SYSTEM HAD REVEALED ONE IMPEDANCE VALUE REMAINED LESS THAN 50 OHMS. THE INTERROGATION NUMBERS OBTAINED WERE: ELECTRODE IMPEDANCE 646, 654, 850, 789, <50, 1076, 1058; OTHER VALUES WERE DEEMED TO BE WITHIN NORMAL LIMITS. THE LEFT-BATTERY IMPEDANCE WAS 927 WITH CURRENT OF 29, AND BATTERY VOLTAGE WAS 3.74, THE BATTERY "WAS READING OK." THE PATIENT ELECTRODE SETTINGS WERE 3+, 0-, AMPLITUDE WAS 1.8, PULSE WIDTH WAS 90, AND PULSE RATE WAS 130. WHEN THE HCP "TRIED TO GO HIGHER ON HIS AMPLITUDE THE RIGHT-SIDE OF HIS FACE WENT NUMB, AND HIS ABILITY TO SPEAK DECREASED." THE PULSE WIDTH AND PULSE RATE WERE TURNED DOWN TO THE SETTINGS LISTED ABOVE, BUT THEY "COULD NOT GO ANY HIGHER ON THE AMPLITUDE WITHOUT GETTING SIDE EFFECTS." THE PATIENT STATED HE WAS COMFORTABLE AT THE PRIOR SETTINGS AND HIS RIGHT ARM TREMOR WAS GONE. HE HAD NOT TAKEN ANY MEDICATIONS SINCE THE PREVIOUS EVENING AND THE PATIENT WAS DISCHARGED TO HOME (NURSING HOME), IN 2007. AT FOLLOW-UP THE FOLLOWING MONTH, THE PATIENT REPORTED HE FELT "THE SAME" AND WAS TIRED; HE HAD CONTINUED TO WORK WITH PHYSICAL THERAPY AND HAD FELT STRONGER. THE PATIENT COULD "WALK ABOUT 5 STEPS BEFORE HIS LEGS GIVE OUT." THERE HAD BEEN NO FALLS OR SYNCOPE SYMPTOMS SUBSEQUENT TO HOSPITAL DISCHARGE. THE PATIENT HAD TURNED DBS THERAPY OFF; HE ATTRIBUTED INCREASED WEAKNESS AND DIARRHEA, INCLUDING THE LOSS OF BOWEL CONTROL TO THE DEVICES. HE HAD THE ONSET OF GASTROINTESTINAL UPSET AND DIARRHEA WITHIN 2-3 HOURS WHEN STIMULATION IS TURNED ON THAT RESOLVED WHEN THERAPY IS TURNED OFF. THE PATIENT HAD "REPEATED THIS SCENARIO WITH CONSISTENT RESULTS, UNABLE TO USE DBS IMPLANT," THE PATIENT HAD LEFT STIMULATION OFF TO AVOID THE AFFECTS OF DIARRHEA. ON THE SAME DAY, (VISIT NOTES CONTINUED): THE PATIENT CONTINUED WITH RIGHT-SIDED TREMOR, SYMPTOMS WERE GREATER IN THE RIGHT-HAND THAN THE LEG; THE PATIENT REPORTED "TROUBLE TURNING IN AT NIGHT." HE WAS EATING AND DRINKING WELL AND HAD USED LORTAB FOR RIGHT-HIP AND BACK PAIN WITH GOOD RELIEF. RESULTS OF PHYSICAL EXAM HAD SHOWN THE PATIENT WAS WELL-GROOMED, WELL-NOURISHED IN NO ACUTE DISTRESS; HIS ATTENTION SPAN AND CONCENTRATION WERE NORMAL AND IN NO ACUTE DISTRESS; HIS ATTENTION SPAN AND CONCENTRATION WERE NORMAL AND APPROPRIATE FOR HIS AGE AND EDUCATION LEVEL. THE PATIENT'S SPEECH HAD BEEN CLEAR, HIS SMILE WAS DEEMED SYMMETRICAL AND INTACT. THERE WAS RIGHT-UPPER EXTREMITY RESTING TREMOR, THEY WERE UNABLE TO TEST GAIT. THE PATIENT WOULD CONTINUE WITH CURRENT MEDICATIONS, HE WOULD TAKE ROZEREM EVERY NIGHT. AT FOLLOW-UP FIVE DAYS LATER, THE DBS THERAPY HAD REMAINED OFF DUE TO UNCOMFORTABLE BOWEL MOVEMENTS. THE PATIENT HAD INDICATED THAT HE HAD NOT EXPERIENCED UNCONTROLLABLE BOWEL MOVEMENTS SUBSEQUENT TO TURNING OFF STIMULATION THERAPY. IT WAS ALSO "NOTED THAT BEFORE THIS BATTERY CHANGE HE WAS UP AND WALKING, BUT IS NOW IN A WHEELCHAIR, AND HE STATED THAT HIS LEGS FELT LIKE RUBBER." THE HCP INDICATED THAT THE PATIENT HAD BEEN PROGRAMMED UNTIL RIGHT-FACIAL PULLING WAS DETECTED AND THE PATIENT REPORTED TINGLING IN HIS RIGHT-HAND AND RIGHT-FOOT; "IT WAS VERY DIFFICULT TO TURN UP ANY OF THE CONTROLS BECAUSE HE WOULD GET RIGHT FACIAL PULL AND TINGLING IN HIS RIGHT HAND AND FOOT." SYSTEM ADJUSTMENTS WERE REPORTED AS: ELECTRODE SETTINGS, 3+, 0-, AMPLITUDE 1.6, PULSE WITH 90, PULSE RATE 100. IMPEDANCE READINGS WERE 868, 881, 1022, 1049, <50, 1227, 1424, 1227, 1441, 1239. BATTERY IMPEDANCE WAS 1132, CURRENT 25, BATTERY VOLTAGE WAS 3.75, THE READING WAS "OK." THE SINEMET CR 50/200 MEDICATION WAS INCREASED TO TWELVE TABLETS DAILY; ALL OTHER MEDICATIONS REMAINED UNCHANGED. THE NEXT DAY, THE PATIENT WAS SEEN AT THE CLINIC FOR SUTURE REMOVAL FROM THE SCALP POST-REPLACEMENT OF THE LEFT-SIDED EXTENSION; THE INCISION HAD BEEN WELL-HEALED, THE SUTURES HAD BEEN REMOVED WITHOUT DIFFICULTY. THE PATIENT WAS SEEN FOR FOLLOW-UP THE FOLLOWING MONTH, VISIT NOTES HAD BEEN UNAVAILABLE. THE PATIENT WOULD BE REFERRED FOR FURTHER EVALUATION OF THE DBS SYSTEM AND WOULD BE REFERRED TO THE NEUROSURGEON, IF NEEDED. THE PATIENT OUTCOME HAD BEEN REPORTED AS NON-SERIOUS ILLNESS OR INJURY RELATED TO GI SYMPTOMS OF DIARRHEA. REFER TO MFR REPORTS #6000153200704467, #2182207200800451, #2182207200800452, #6000153200800453, #2182207200800454.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0209882V

Patients

Seq Age Sex Outcome Treatment
1 72 YR Required Intervention LACTOBACILLUS ACIDOPHILLUS| MIRAPEX| OMEPRAZOLE| SINEMET CR| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROPRANOLOL| GLYBURIDE| PROZAC| LORTAB| AMBIEN| FLORINEP| IMPLANTED:| HYDROCORTISONE| IMPLANTABLE PULSE GENERATOR: MODEL 7426, LOT# UNK| ERYTHROMYCIN (APPLY TO AFFECTED EYES TWICE WEEKLY)| LEVOTHYROXINE SODIUM| RAMELTEON (ROZEREM| ACETAMINOPHEN| MITRAZOL| EXTENSION: MODEL UNK, LOT# UNK