SYNCHROMED II
Report
- Report Number
- 3004209178-2019-09872
- Event Type
- Injury
- Date Received
- May 20, 2019
- Date of Event
- December 1, 2017
- Report Date
- May 20, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169508156
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS:PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UBD: 01-JUN-2003, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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¿S BODY BETWEEN THE POCKET AND SPINE INCISIONS, WHICH IS THEN SEVERED, AND A PIECE OF SPINAL SEGMENT REMAINS IN THE SPINAL CANAL. AT THIS TIME THERE ARE NO FURTHER ACTIONS PLANNED OR DISCUSSED. THE DIAGNOSTICS AND TROUBLESHOOTING PERFORMED WAS THE PHYSICIAN HAD A PEER TO PEER DISCUSSION AND SPOKE TO THE MANUFACTURER REGARDING THE PATIENT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND IT WAS NOTED THAT THE PHYSICIAN WOULD NOT HAVE ANY FURTHER INFORMATION REGARDING THE EVENT. THE PATIENT STATUS WAS NOTED AS ALIVE NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417289 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00643169508156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |