RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-07098
- Event Type
- Injury
- Date Received
- April 30, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
(B)(4)
(B)(4).
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY. ANALYSIS OF THE LEAD (MODEL 3888-45 LOT # V841065) REVEALED NO SIGNIFICANT ANOMALY, BUT IT WAS NOTED THE CONDUCTORS WERE SEVERELY STRETCHED AND THE #3 CONDUCTOR WAS BROKEN AT THE #3 ELECTRODE WELD SITE DUE TO OVERSTRESS OR DAMAGE. IT WAS ALSO NOTED THERE WERE MULTIPLE COSMETIC MELTED SPOTS IN THE OUTER INSULATION. ANALYSIS OF THE LEAD (MODEL 3888-45 LOT # V389409) REVEALED NO SIGNIFICANT ANOMALY, BUT IT WAS NOTED ALL THE CONDUCTORS WERE SEVERELY STRETCHED AND BROKEN IN THE ELECTRODE AREA OF THE LEAD. THE OUTER INSULATION WAS BROKEN UNDER THE #2 AND #3 ELECTRODES. IT WAS ALSO NOTED THERE WERE MULTIPLE COSMETIC MELTED SPOTS IN THE OUTER INSULATION, CAUTERY WAS SUSPECTED. IN THE PROXIMAL SEGMENT, THE #4 AND #5 CIRCUITS HAD ACCEPTABLE CONTINUITY BETWEEN THE CONNECTOR AND DISTAL BREAKS, AND THE #6 AND #7 CIRCUITS WERE OPEN BETWEEN THE CONNECTOR AND DISTAL BREAKS. IT WAS NOTED A TITAN ANCHOR WITH A SUTURE ATTACHED WAS RECEIVED SITTING LOOSE OVER THE #2 ELECTRODE. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4).) REVEALED NO SIGNIFICANT ANOMALY, BUT IT WAS NOTED THE OUTER INSULATION WAS MELTED. IT WAS SUSPECTED THE MELTED INSULATION WAS DUE TO CAUTERY ARTIFACT. ANALYSIS OF THE LEAD (MODEL 3778-60) REVEALED NO SIGNIFICANT ANOMALY, BUT IT WAS NOTED CONDUCTORS WERE BROKEN DUE TO OVERSTRESS OR DAMAGE. THE #0 CONDUCTOR WAS BROKEN UNDER THE #1 ELECTRODE, AND THE #1 CONDUCTOR WAS BROKEN AT THE #1 ELECTRODE CRIMP SLEEVE. IT WAS NOTED THE OUTER INSULATION AND STYLET COIL WERE BROKEN AT THE #2 ELECTRODE. THE #0 AND #1 ELECTRODES ALONG WITH THE INSULATION WERE PULLED OFF THE LEAD. ANALYSIS OF THE ANCHOR REVEALED NO ANOMALY.
(B)(4).
PRODUCT ID 3888-45, LOT# V841065, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V389409, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID NEU_UNKNOWN_EXT, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
PRODUCT ID: 3888-45 LOT# V841065, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3888-45 LOT# V389409, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION STATED THE MASS WAS NOT DEVICE RELATED AND THE SWELLING HAD SINCE SUBSIDED. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AS OF THE TIME OF REPORT BUT THEY WERE SCHEDULED FOR A REPROGRAMMING SESSION THREE WEEKS FROM THE TIME OF REPORT.
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT RECEIVED STIMULATION IN THE LEFT SIDEAND ANTERIOR COVERAGE ONLY. IT WAS ALSO REPORTED THAT THE PATIENT HAD A ¿LUMP¿ UNDER THEIR LEFT RIB CAGE THAT CAUSED THEM EXTREME PAIN. THE PATIENT HAD AN X-RAY WHERE IT WAS NOTED THAT IT SHOWED ¿SOME SORT OF MASS¿ BUT IT WAS UNKNOWN AS TO WHAT IT WAS AND THE CAUSE. THE PATIENT WAS TO MEET WITH THE MANUFACTURER¿S REPRESENTATIVE IN A COUPLE OF WEEKS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT WITH A NEW SYSTEM AND PADDLE LEAD. IT WAS LATER REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT OUTCOME WOULD NOT BE KNOWN FOR A COUPLE WEEKS. IT WAS LATER REPORTED THAT THE PATIENT¿S DEVICES WERE EXPLANTED AND REPLACED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE PADDLE ELECTRODE WAS IMPLANTED THE PATIENT WAS VERY SORE. A MANUFACTURER REPRESENTATIVE WAS TO MEET WITH THE PATIENT IN ONE WEEK AFTER THE PATIENT HAD MORE TIME TO HEAL IN ORDER TO DO SOME FINE TUNING WITH THE NEW IMPLANTABLE NEUROSTIMULATOR.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION.
IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING JOLTING SENSATION. THE PATIENT EXPERIENCED THE SENSATION WHEN THE MANUFACTURER REPRESENTATIVE CHECKED IMPEDANCES, AND ONCE ONE MONTH AGO DURING NORMAL EVERYDAY USE. WHEN THE IMPEDANCE WAS SUBSEQUENTLY CHECKED AT 0.7 VOLTS THERE WAS NO JOLTING SENSATION AND ALL IMPEDANCES WERE WITHIN NORMAL RANGE. WHEN THE VOLTAGE WAS INCREASED TO 1.5V AND IMPEDANCES WERE CHECKED THE PATIENT EXPERIENCED A VERY PAINFUL SHOCKING JOLT, AND FURTHER TESTING WAS CANCELED. THE PATIENT PLANNED TO HAVE A REVISION TO PLACE A PADDLE LEAD, AND THEY PLANNED TO CONSIDER CHANGING OUT THE GENERATOR AT THAT POINT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AND PAIN IN THE DEVICE POCKET OF THE RIGHT SIDE IMPLANT. IT WAS LATER REPORTED THAT THE PATIENT HAD TWO EPIDURAL OCTAD LEADS FOR PAIN IN THE BACK AND DOWN THE LEGS. SHE WASN'T GETTING GOOD PAIN RELIEF SO HER HCP IMPLANTED SUBCUTANEOUS QUAD LEADS IN HER LOWER BACK. THE SUBCUTANEOUS LEADS BECAME FOLDED UP UNDER THE SKIN AND WERE STICKING OUT SO THAT BECAME VERY UNCOMFORTABLE FOR THE PATIENT, WHO ASKED THAT THEY NO LONGER BE PROGRAMMED. THE PATIENT WAS GETTING SOME STIMULATION BENEFIT FROM THE EPIDURAL LEADS THAT REMAINED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THREE PAINFUL SHOCKS AT THE INS SITE. TWO OCCURRED DURING IMPEDANCE CHECKS AND ONE OCCURRED WHEN THE PATIENT WAS SITTING AT A PICNIC TABLE WITH HER FAMILY. THE SHOCKING WHILE SITTING AT THE PICNIC TABLE DID NOT STOP UNTIL SHE TURNED HER STIMULATOR OFF. THE PATIENT USUALLY USED STIMULATION AT 2-3V. IT WAS NOTED THAT THE PATIENT WAS VERY SENSITIVE EVERYWHERE ON HER BODY SO IT WAS NOT KNOWN IF PALPATION CAUSED SHOCKING. THE PATIENT WAS USING ADAPTIVE STIM AND IT WAS NOTED THAT SHE HAD NO ISSUES WITH THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186532 | 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 | 00049 YR | Required Intervention |