FDA Adverse Event
Injury
Summary report: N
RESUME
MDR report key: 1000120
·
Received February 19, 2008
Report
- Report Number
- 2182207-2008-00778
- Event Type
- Injury
- Date Received
- February 19, 2008
- Date of Event
- October 1, 2006
- Report Date
- January 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- K884948
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE PT REPORTED THAT HER DEVICE HAD MALFUNCTIONED FIVE MONTHS AFTER SYSTEM PLACEMENT; THE LEADS WOULD "PULL ON THE PT'S NERVES" AND THE "IMPLANTED SYSTEM HURTS HER." SHE HAD EXPERIENCED NAUSEA, SEVERE HEADACHE, AND MOTOR WEAKNESS; THE SYMPTOMS HAD BEEN DETECTED AT THE LEAD LOCATION AND AT THE AREA OF PARESTHESIA. THE REPRESENTATIVE REDIRECTED THE PT TO REPORT SYMPTOMS TO THE HCP. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. REFER TO MFR REPORT #2182207200800777 AND 2182207200800783.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESUME | GZF/GZB | GZF | MEDTRONIC NEUROMODULATION | 3587A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT056748P| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU101148V| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU111168V| IMPLANTED:| EXPLANTED:| LOT# NFE152746H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7427 |