PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-11142
- Event Type
- Injury
- Date Received
- July 1, 2013
- Report Date
- June 10, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT IT WAS FUNCTIONALLY OKAY AND ONLY INSIGNIFICANT ANOMALIES WERE NOTED.
CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR REMOVAL WAS THAT THE PATIENT COMPLAINED OF SHOCKING. IT WAS NOTED THAT THE PATIENT CONTACTED THE PHYSICIAN'S OFFICE WHO THEN CONTACTED THE MANUFACTURING REPRESENTATIVES TO CHECK THE PATIENT'S STIMULATOR. IT WAS NOTED THAT THE PATIENT WAS SEEN IN THE OFFICE AT SOME POINT AND HAD THE DEVICE EVALUATED. IT WAS FURTHER NOTED THAT NO IRREGULARITIES WERE FOUND. IT WAS NOTED THAT THE PATIENT THEN DECIDED HE WANTED THE DEVICE REMOVED. IT WAS NOTED THAT IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED ON (B)(6) 2013 DUE TO SHOCKING. IT WAS NOTED THAT IT WAS NOT BELIEVED THAT THE PATIENT SYMPTOMS WERE FROM THE DEVICE AND "HAD OCCURRED MORE RECENTLY. "A MANUFACTURE REPRESENTATIVE HAD REPORTEDLY SEEN THE PATIENT ON 2013-06-13 AND NOTED THAT THEY WERE UNABLE TO FIND ANY DEVICE MALFUNCTION AT THAT TIME. IT WAS FURTHER NOTED THAT THE PATIENT WAS LEGALLY BLIND AND BOTH THE HUSBAND AND WIFE SEEMED TO BE CONFUSED WITH THE OPERATING OF THE PATIENT PROGRAMMER AND THE INS. THE PATIENT HAD REPORTEDLY TOLD THEIR HEALTH CARE PROVIDER THAT THEY WANTED THE INS REMOVED. IT WAS NOTED THAT THE HEALTH CARE PROVIDER ONLY REMOVED THE INS AND THE LEAD S WERE LEFT INTACT.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING AND JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT REPORTED A SHOCKING SENSATION ¿AT TIMES LIKE 2 A.M. AND 5 A.M." IT WAS NOTED THAT THE PATIENT REPORTED A FALL APPROXIMATELY ONE MONTH PRIOR TO REPORT AND THAT THIS OCCURRED "OCCASIONALLY." IT WAS NOTED THAT THE PATIENT¿S UNIT WAS TURNED OFF AND THE AMPLITUDE SET AT 0.0. IT WAS NOTED THAT THE PATIENT SAW THE IMPLANTING PHYSICIAN A WEEK PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. IT WAS FURTHER NOTED THAT THE PATIENT HAD A SCHEDULED APPOINTMENT WITH THE PAIN PHYSICIAN ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT'S SYMPTOMS INCLUDED PAIN AND SHOCKING IN BACK. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS SEEN IN THE OFFICE A DAY PRIOR TO REPORT AND THE DEVICE WAS NOT TURNED OFF. PATIENT WAS TURNING THE DEVICE ON, NOT OFF, AND DURING THE NIGHT HE OCCASIONALLY RECEIVED WHAT HE CALLED A ¿SHOCKING¿ SENSATION. IT WAS NOTED THAT THE PATIENT WAS INSTRUCTED ON THE ¿OFF¿ BUTTON AND LEFT THE OFFICE WITH THE DEVICE OFF. IT WAS NOTED THAT THERE WERE NO FURTHER REPORTS OF A SHOCKING SENSATION BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300032 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention |