RESTORE ULTRA
Report
- Report Number
- 3004209178-2014-11495
- Event Type
- Injury
- Date Received
- June 12, 2014
- Report Date
- May 23, 2014
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN OUT OF REGULATION (OOR) MESSAGE WAS SEEN ON 2015 (B)(6). BROKEN LEAD WIRES WERE ALSO REPORTED. THE PATIENT WAS TOLD BY A MANUFACTURER REPRESENTATIVE (REP) IN 2015 (B)(6) THAT 3 OF 16 WIRES WERE NOT WORKING AND THE OTHER 13 WERE BENT/BROKEN. FOLLOW-UP DETERMINED THAT THE REP HAD MET WITH THE PATIENT ON 2015 (B)(6). THE REP WAS NO LONGER SEEING THE PATIENT AS THEY WERE IN A DIFFERENT DISTRICT AND THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
IT WAS REPORTED THE PATIENT SAW AN OUT OF REGULATION (OOR) MESSAGE ON THEIR PROGRAMMER. IT WAS NOTED THE PATIENT STARTED TO SEE THE OOR MESSAGE THE DAY BEFORE YESTERDAY. IT WAS FURTHER NOTED THE PATIENT WAS TRYING TO INCREASE STIMULATION. THE REPORTER STATED THEY WERE ABLE TO BYPASS THE OOR MESSAGE. THE REPORTER FURTHER STATED THEY WERE ABLE TO INCREASE STIMULATION AFTER BYPASSING THE MESSAGE. IT WAS NOTED THE PROGRAMMER SHOWED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS 1/4 FULL. IT WAS FURTHER NOTED THE PATIENT USED TO ONLY HAVE TO CHARGE THE INS EVERY THREE WEEKS. THE REPORTER STATED THAT STARTING ABOUT A MONTH AGO THEY HAD TO CHARGE EVERY FIVE DAYS. THE REPORTER FURTHER STATED THAT ALL OF A SUDDEN STIMULATION WOULD STOP AND THEN THEY HAD TO CHARGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT IN RESPONSE TO FOLLOW-UP REPORTED THAT THEY WERE SCHEDULED FOR LEAD REPLACEMENT SURGERY IN (B)(6).
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT WHEN THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE THE PATIENT WAS GETTING SHOCKED AS THE REPRESENTATIVE WAS ADJUSTING IT. THE PATIENT STATED THE REPRESENTATIVE SAID SOMETHING ABOUT THE LEADS BEING BROKEN AND THE IMPLANT WAS UNUSABLE. FURTHER INFORMATION RECEIVED FROM THE REPRESENTATIVE NOTED THAT BACK IN (B)(6) HE MET WITH THE PATIENT AT THE HCP'S OFFICE REGARDING HER PAIN ISSUES NOT RELATED TO THE STIMULATOR. THE PATIENT DID NOT MENTION ANY ISSUES WITH SHOCKING WHEN THE REPRESENTATIVE CHECKED THE DEVICE. THE REPRESENTATIVE DID FIND HIGH IMPEDANCE ON ONE ELECTRODE. NO INFORMATION AS TO WHAT ACTIONS WERE TAKEN WERE AVAILABLE. IT WAS NOTED THAT THE PATIENT ASKED ABOUT HAVING THE DEVICE REPLACED WITH A DIFFERENT MANUFACTURER'S DEVICE AND WAS REFERRED TO THE SURGEON. THE REPRESENTATIVE LEARNED THE PATIENT WAS SEEN FOR A NUMBER OF REPROGRAMMINGS PRIOR TO THE VISIT IN (B)(6), BUT NO ADDITIONAL INFORMATION WAS AVAILABLE WITH RESPECT TO THOSE REPROGRAMMINGS. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE STEPS TAKE TO RESOLVE THE REPORTED ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348769 | 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 | 00062 YR | Required Intervention |