FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2181578
·
Received July 5, 2011
Report
- Report Number
- 3004209178-2011-05070
- Event Type
- Malfunction
- Date Received
- July 5, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 8, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE (B)(6) THE PATIENT FELL AND HIT THE RIGHT SIDE OF THE HEAD, AFTER WHICH THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT THAT (B)(6). IMPEDANCE READINGS ON THE RIGHT SIDE INS WERE >2000 OHMS ON SOME OF THE UNIPOLAR PAIRS. PREVIOUS READINGS TAKEN IN LATE MAY WERE WITHIN NORMAL RANGE. IMPEDANCE READINGS TAKEN ON THE LEFT SIDE INS WERE WITHIN NORMAL RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MFR REPORT # 3004209178-2011-05069 REGARDING THE PATIENT'S OTHER DEEP BRAIN STIMULATOR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU007143V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0230919V| LOT# NFW129791H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| PROGRAMMER: MODEL 7438, LOT# NHL005966P| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0231061V| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU105055V |