FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1760497
·
Received July 15, 2010
Report
- Report Number
- 3004209178-2010-05510
- Event Type
- Injury
- Date Received
- July 15, 2010
- Date of Event
- June 17, 2010
- Report Date
- June 17, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DEEP BRAIN STIMULATOR BATTERY WAS DEPLETED. DURING REPLACEMENT SURGERY, A NEW EXTENSION WAS TUNNELED. THE SURGEON PULLED ON WHAT HE THOUGHT WAS THE NEW EXTENSION TO THREAD IT THROUGH THE TUNNEL. HOWEVER, HE WAS PULLING ON THE OLD EXTENSION, STILL CONNECTED TO THE OLD RIGHT-SIDED LEAD. THE SURGEON DIDN'T UNDERSTAND WHY IT WAS STUCK, SO HE PULLED HARDER. HE PULLED SO HARD THAT HE SEVERED THE LEAD. THE LEAD WAS REPLACED WITHOUT COMPLICATIONS DURING A SEPARATE SURGERY. THE PT EXPERIENCED A RETURN OF SYMPTOMS IN THE INTERIM PERIOD. THE NEW DEVICE SYSTEM WAS REPROGRAMMED AND THE PT HAS BENEFICIAL THERAPEUTIC EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL005901P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0228080V| EXTENSION: MODEL 7482, LOT# NGK019251N |