SURESCAN
Report
- Report Number
- 3004209178-2018-15640
- Event Type
- Malfunction
- Date Received
- July 12, 2018
- Date of Event
- June 10, 2018
- Report Date
- October 5, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: (B)(4). ANALYSIS OF THE RECHARGER (B)(4) FOUND EVIDENCE OF BROKEN CONNECTOR PINS. APPLY TO THE IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ON (B)(6) 2018, CRTS 3725032, RPL 210982 (CON) INFORMATION WAS RECEIVED REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS), AND IT WAS REPORTED THAT THE DESKTOP CHARGER CONNECTOR PIN WAS BROKEN SO THE PATIENT COULD NOT CHARGE THE INS, AND THE PATIENT WAS IN A LOT OF PAIN AS A RESULT. PATIENT WAS ISSUED A NEW DESKTOP CHARGER. THERE WERE NO REPORTED COMPLICATIONS AND NO FURTHER COMPLICATIONS WERE EXPECTED. PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526104 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |