RESTORE ADVANCED
Report
- Report Number
- 3004209178-2014-14934
- Event Type
- Injury
- Date Received
- August 8, 2014
- Report Date
- July 15, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE STIMULATOR WAS FUNCTIONALLY OKAY.
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 355029, LOT# N090693, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. (B)(4).
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT PRODUCTS: PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 355029, LOT # N090693, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY.
IT WAS REPORTED THAT THE HIGH IMPEDANCES WERE SEEN ON ELECTRODES #0, 1, AND 6 OF THE LEAD COMPONENT OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO REPORTED THAT THE LEAD WAS FRACTURED. IN ADDITION, THE PATIENT HAD A LOW GRADE INFECTION WITH SWELLING AT THE INS POCKET. THE CAUSE OF THE ISSUES WAS NOT DETERMINED. THE PLAN WAS EXPLANT, THE DEVICE AND TO RE-IMPLANT THE PATIENT AFTER A MINIMUM OF 4 WEEKS POST-OPERATION. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE NO INJURY¿. FOLLOW UP INFORMATION RECEIVED 3 DAYS LATER REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE REPORTED AS >10,000 AT 0.7 AND >20,000 AT 1.5. ALSO, THE LOCATION OF THE LEAD FRACTURE WAS NOT KNOWN. THE DATE FOR THE EXPLANT PROCEDURE HAD NOT BEEN SCHEDULED AS OF THE TIME OF REPORT. THERE WERE NO FURTHER INTERVENTIONS OR OUTCOME HAD BEEN REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION STATED THE INFECTION AT THE POCKET SITE REQUIRED AN EXPLANT THAT WAS SCHEDULED FOR (B)(6) 2014. IN ADDITIONAL TO THE INFECTION IT WAS NOTED THE PATIENT¿S DEVICE POCKET EXHIBITED DRAINAGE AND INCISIONAL WOUND OPENING AT THE TIME OF FOLLOW-UP. THE PATIENT WAS REPORTEDLY ¿DOING WELL¿ AS OF THREE DAYS AFTER THE SCHEDULED EXPLANT.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REGARDING INFORMATION RELATED TO THEIR EXPLANT ALREADY REPORTED STATED THEY HAD A CONFIRMED INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE ON THE RIGHT SIDE. SYMPTOMS REPORTED INCLUDED REDNESS, SWELLING, PAIN, AND THE INS ERODING OUT THE SKIN WHICH WERE SUDDEN CHANGES. IT WAS NOTED THE INS WAS FINE FOR SEVEN YEARS, BUT THE DOCTOR THOUGHT THE CAUSE OF THE INS ISSUE WAS WEIGHT GAIN AT THE POCKET SITE. AS A RESULT THE PATIENT WAS GIVEN BOTH IV AND ORAL ANTIBIOTICS AND UNDERWENT A TOTAL SYSTEM EXPLANT. THE PATIENT WANTED A SYSTEM RE-IMPLANTED BUT THE INSURANCE DENIED IT STATING IT WAS EXPERIMENTAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470828 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |