FDA Adverse Event Malfunction Summary report: N

SOLETRA

MDR report key: 3953652 · Received July 23, 2014

Report

Report Number: 3004209178-2014-13449
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: July 2, 2014
Report Date: July 2, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V064265, IMPLANTED:(B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V049666, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THEY SAW AN OUT OF REGULATION (OOR) MESSAGE. THE PATIENT HAD BENEFIT AT THE TIME OF REPORT. IT WAS FURTHER REPORTED THE IMPEDANCE ISSUE OCCURRED AFTER SURGERY AND THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT DETERMINED. IT WAS UNKNOWN IF IT WAS DEVICE RELATED AND NO LEAD FRACTURES WERE NOTED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE NEW INS WAS CHECKED ON (B)(6) 2014 AND IT WAS STILL LOW AT 253 THERAPY IMPEDANCE. THEY HAD CHANGED THEIR SETTINGS AND IT WAS AT 662 OHMS. THE PATIENT STILL HAD TREMOR CONTROL WITH NO SIDE EFFECTS. THE PATIENT HAD SEEN THE OOR MESSAGE AND THEY STILL HAD TREMOR CONTROL AT THAT TIME WITH NO SIDE EFFECTS. THEY HAD NOT PLANNED TO RETURN TO THEIR HEALTH CARE PROFESSIONAL¿S CLINIC UNTIL (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431071	SOLETRA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	7426

Patients

Seq	Age	Sex	Outcome	Treatment
1	00076 YR