FDA Adverse Event Injury Summary report: N

SOLETRA

MDR report key: 3497794 · Received December 3, 2013

Report

Report Number: 3004209178-2013-21816
Event Type: Injury
Date Received: December 3, 2013
Report Date: November 13, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3389S-40 LOT# V135142, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# V127831, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CALLER HAD THERAPEUTIC BENEFIT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT THE VALUES WERE A BIT HIGH. IT WAS NOTED THAT IMPEDANCE WAS MEASURED AS THE FOLLOWING: C-0 1049, C-1 >2K, C-2 1304, C-3 >2K, 0-1 >2K, 0-2 1695 AND ALL THE REST WERE >2K. IT WAS REPORTED THAT THE PATIENT HAD BOTH OF THEIR DEVICES REPLACED ABOUT 1.5 YEARS PRIOR TO REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
624642	SOLETRA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	7426

Patients

Seq	Age	Sex	Outcome	Treatment
1	00040 YR		Required Intervention