FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3140610
·
Received May 31, 2013
Report
- Report Number
- 3007566237-2013-01820
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- May 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241013 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR | Required Intervention |