RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-06999
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 11, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
CORRECTION: ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CORRECT AWARE DATE WAS (B)(6) 2013.
CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).
CORRECTION: AWARE DATE WAS CHANGED TO (B)(6) 2013, AS WHEN THE MANUFACTURER REPRESENTATIVE FIRST WAS MADE AWARE OF THE OVERDISCHARGE.
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A LEAD REVISION; AS IT WAS IMPLANTED IN THE 'WRONG SPOT.' IT WAS STATED THAT THE REPORTER WAS CONFUSED ON WHAT HER PHYSICIANS WERE TELLING HER, BUT SHE SAID THAT THE DEVICE WAS RUNNING AT THE 'WRONG LEVEL.' IT WAS NOTED THAT THE PATIENT DID NOT HAVE ADAPTIVE STIMULATION ACTIVE YET, BUT WANTED IT ENABLED. THE PATIENT'S DEVICE HAD NOT BEEN ON FOR A YEAR BECAUSE IT CAUSED PAIN AT THE CHEST LEVEL. IT WAS STATED THE PATIENT FELT 'PINCHING IN HER HEART AND LUNGS' IT WAS SO HIGH SHE COULD NOT BREATHE WHEN STIMULATION WAS ON. IT WAS NOTED THAT THE SURGEON WANTED TO REPLACE THE DEVICE AND THE ANESTHESIOLOGIST WANTED TO 'JUMP START' THE CURRENT DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT WAS GOING TO ATTEMPT A PHYSICIAN MODE RECHARGE (PMR) WITH THE ASSISTANCE OF THE MANUFACTURER REPRESENTATIVE OVER THE PHONE. IT WAS NOT NOTED IF THE PMR WAS SUCCESSFUL. THE PATIENT WAS INSTRUCTED THAT HER DEVICE WOULD NEED TO BE RESET BY THE CLINICIAN PROGRAMMER. THE REPORTER STATED THAT THE DEVICE WOULD NOT HOLD A CHARGE AND THAT SHE WAS RECHARGING EVERY 48 HOURS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN WAS MOVING THE PADDLE LEAD FOR BETTER COVERAGE. THE REPORTER WANTED TO KNOW THE BEST WAY TO TEST IMPEDANCES ON AN OVERDISCHARGED DEVICE. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STOPPED GETTING GOOD COVERAGE IN THE SPRING OF 2012. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED APPROXIMATELY TWO MONTHS AGO. THE PMR WAS SAID TO HAVE BEEN UNSUCCESSFUL AND SENT THE DEVICE BACK INTO OVERDISCHARGE. IT WAS STATED THAT THE PATIENT WAS NOT GETTING GOOD PAIN RELIEF, SO SHE WAS RE-TRIALED AT THE END OF (B)(6) 2013. THE DEVICE WAS REPLACED LAST FRIDAY ((B)(6) 2013). IT WAS ADDED THAT THE PADDLE LEAD WAS REPOSITIONED TO A 'MORE IDEAL' LOCATION. THE SURGERY WAS STATED AS SUCCESSFUL AND THE PATIENT WAS CURRENTLY HEALING.
IT WAS REPORTED A YEAR AND A HALF LATER THAT A DEEP DISCHARGE OCCURRED AFTER A YEAR OF NOT HAVING ANY KIND OF GOOD QUALITY COVERAGE AND NEEDING A REVISION. THE PATIENT DID NOT WANT TO GET OUT OF THE DEEP DISCHARGE BY HERSELF FOR 18 HOURS ON HER OWN. THE REVISION WAS DUE BECAUSE HER UNIT WAS IN THE WRONG PLACE, THE PADDLE WAS UP IN THE T6 AND NEEDED TO BE DOWN IN THE T10.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183414 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Required Intervention |