FDA Adverse Event
Injury
Summary report: N
ISOLETRA
MDR report key: 1920091
·
Received December 3, 2010
Report
- Report Number
- 3004209178-2010-10181
- Event Type
- Injury
- Date Received
- December 3, 2010
- Date of Event
- January 1, 2007
- Report Date
- November 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DEEP BRAIN STIMULATOR LEAD WAS REPLACED BECAUSE IT BROKE (REFERENCE MFG. REPORT #3004209178-2010-06189). AFTERWARD HE DID NOT GET THE SAME GOOD RESULTS AS WITH THE INITIAL IMPLANT. THE BATTERIES WERE REPLACED. THE HCP BELIEVED THERE WAS SCAR TISSUE OR THAT THE DEEP BRAIN STIMULATOR LEAD HAD MIGRATED. THE HCP WANTED TO CREATE A NEW BURR HOLE, ADJACENT TO THE EXISTING ONE AND REINSERT A NEW ELECTRODE INTO THE PATIENT'S RIGHT BRAIN. THE LEAD WAS REPLACED. AT A FOLLOW UP VISIT ABOUT 6 WEEKS LATER THE PATIENT WAS DOING FINE. HE WAS RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXTENSION: MODEL #7482, LOT #NHU126583V| LEAD: MODEL #3387, LOT #V007422| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL #7426,| IMPLANTED:| LEAD: MODEL #3387, LOT #V032543| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL #7482, LOT #NHU150659V| EXPLANTED:| EXTENSION: MODEL #7482, LOT #NHU123435V| IMPLANTED:| LOT #NFW163629H| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: |