FDA Adverse Event
Injury
Summary report: N
UNKNOWN EXTERNAL NEUROSTIMULATOR
MDR report key: 2834352
·
Received November 15, 2012
Report
- Report Number
- 3007566237-2012-02732
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# VA0317G, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3065USC, LOT# N312802, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3057-1SC, LOT# N302467, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PORTION OF THE PATIENT'S TRIAL LEAD "BROKE OFF" AND WAS LEFT INSIDE THE PATIENT. THE PATIENT'S HEALTH CARE PROVIDER (HCP) ATTEMPTED TO RETRIEVE THE FRAGMENT BUT WAS UNSUCCESSFUL. IT WAS NOT KNOWN HOW MUCH OF THE LEAD WAS LEFT INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS "DOING FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN EXTERNAL NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |