FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3200198
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-01131
- Event Type
- Injury
- Date Received
- July 1, 2013
- Report Date
- June 15, 2016
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUPPLEMENTAL SUBMITTED TO CORRECT THE AWARE DATE WHICH SHOULD BE 2012-06-11.
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS OVERDOSED THREE YEARS AGO. THE DRUGS DELIVERED IN THE PUMP WERE HYDROMORPHONE, CLONIDINE AND BACLOFEN (UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
ON 2016-05-23, ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE PATIENT HAD AN OVERDOSE "YEARS AGO" WHERE THEY MIXED UP HIS MEDICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298859 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Other |