FDA Adverse Event Malfunction Summary report: N

SOLETRA

MDR report key: 2810430 · Received October 31, 2012

Report

Report Number: 3004209178-2012-09776
Event Type: Malfunction
Date Received: October 31, 2012
Report Date: October 2, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MRU
PMA / PMN Number: H020007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V113344, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V113344, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S THERAPY IMPEDANCE WAS 590 OHMS, BUT THE PATIENT ALSO HAD SOME OPEN CIRCUITS. IMPEDANCES WERE REPORTED READING GREATER THAN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS, ALL PAIRS WITH #0 WERE ELEVATED OR GREATER THAN 40K, C0=18K AND BIPOLES WERE GREATER THAN 40K WITH #0. THE REPRESENTATIVE ALSO READ LESS THAN 250 OHMS, THE 12 PAIR IMPEDANCE WAS 7 OHMS, 13 AND 23 WERE BOTH 1253 OHMS. THERE WAS NO HISTORICAL IMPEDANCE AVAILABLE. THE PATIENT WAS DOING WELL WITH HER THERAPY. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE REPRESENTATIVE MET WITH THE PATIENT THIS MONDAY TO CHECK THERAPY IMPEDANCE. HER READING FOR THERAPY IMPEDANCE WAS WITHIN NORMAL LIMITS SO NO ACTION WAS TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE REFER TO MANUFACTURER REPORT NO. 3004209178-2012-09775.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SOLETRA	IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)	MRU	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	7426

Patients

Seq	Age	Sex	Outcome	Treatment
1