RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-06793
- Event Type
- Injury
- Date Received
- April 23, 2013
- Report Date
- April 5, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(4).
PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS "UNCOMFORTABLE" WITH THE STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION AS WELL AS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT "T STARTED OUT" WHERE THE PATIENT WAS JUST SITTING AND "IT WENT OFF" BUT WAS STILL SHOWING AS BEING ON. THE PATIENT THEREFORE TURNED IT OFF, WAITED AND TURNED IT BACK ON. THE PATIENT HAD REPORTEDLY KEPT STIMULATION ON BUT COULD NOT CONSISTENTLY FEEL STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT NOTICED THE LACK OF THERAPEUTIC EFFECT AND INTERMITTENT LACK OF STIMULATION SENSATION ON (B)(6) 2013. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD NOTICED THAT STIMULATION "CHANGED POSITIONALLY" AND WHEN THE PATIENT "LEANED FORWARD" SHE GOT "A LITTLE JOLT." THE PATIENT WAS ALSO EXPERIENCING SYMPTOMS OF ACUTE PAIN. ADDITIONALLY, THE PATIENT HAD NOT BEEN GETTING ANY PAIN RELIEF AND HER FEET "HAD BEEN ON FIRE ALL WEEK." THESE SYMPTOMS, AS WELL AS THE CHANGES IN STIMULATION PATTERN, WERE NOTED TO HAVE OCCURRED FOLLOWING A FALL THE PATIENT HAD A MONTH PRIOR TO THE REPORT. THE PATIENT WAS INDICATED TO HAVE MET WITH HER HEALTHCARE PROVIDER (HCP) AND AN X-RAY WAS DONE BUT THE RESULTS WERE NOT AVAILABLE AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, AN ATTEMPT WAS MADE TO TRY ALL THE PATIENT'S PROGRAMS BUT NONE OF THEM WORKED FOR HER. ONE OF THE PATIENT'S PROGRAMS WAS NOTED TO HAVE BEEN WORKING "SOMEWHAT" BUT WAS THE PROGRAM THAT "DID THE PATIENT'S RIBS REALLY BAD." IT WAS ALSO NOTED THAT THE FEELING OF STIMULATION WAS GOING "ON AND OFF" AND THE PATIENT WAS FEELING NO STIMULATION AT THE TIME OF THE REPORT. IT WAS LATER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED AND TROUBLESHOOTING WAS DONE ON (B)(6) 2013. IT WAS UNCLEAR WHAT THE OUTCOME OF THE INTERROGATION WAS. THE PATIENT WAS ALSO REPROGRAMMED THAT SAME DAY BUT STIMULATION WAS STILL INTERMITTENT. THE REPORTER INDICATED THAT THE PATIENT'S HCP DECIDED TO HAVE A SURGICAL REVISION. THE PATIENT WAS REPORTEDLY DOING FINE POST-OPERATIVELY. FOLLOW-UP WITH THE PATIENT'S HCP INDICATED THAT X-RAY RESULTS SHOWED THAT THE LEAD HAD MIGRATED. AS A RESULT, THE PATIENT WAS UNABLE TO FEEL STIMULATION IN HER LEGS AND THORACIC AREA. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED, AND THE LEAD WAS REVISED AND REPOSITIONED. THERE WAS NO PATIENT INJURY AND NO HOSPITALIZATION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175105 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Required Intervention |