FDA Adverse Event Malfunction Summary report: N

SOLETRA

MDR report key: 2920980 · Received January 17, 2013

Report

Report Number: 3004209178-2013-00727
Event Type: Malfunction
Date Received: January 17, 2013
Report Date: August 5, 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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7438 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3387S-40 LOT# V171221, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED< THE DEVICE COULD NOT BE TURNED OFF AND ON BECAUSE, THE PATIENT NO LONGER HAD THE PATIENT PROGRAMMER IN THEIR POSSESSION. A SECOND PROGRAMMER WAS SET TO BE ORDERED FOR THE PATIENT. IT WAS STATED, THE PATIENT HAD NOT BEEN TO ANY HEALTHCARE PROFESSIONAL SINCE (B)(6) 2011, BECAUSE "ANYTIME THEY ARE TUNED UP, IT DOES NOT HELP." IT WAS NOTED THAT THERE WAS "NO IMPROVEMENT" WHEN THE PATIENT LEAVES THE REPROGRAMMING SESSIONS. WHEN THE PATIENT WAS REPROGRAMMED IT WAS STATED "THEY CAN MAKE THEM SHAKE MORE AND THEN SLOW THEM DOWN AND STUFF." THIS WAS STATED TO HAVE OCCURRED SINCE IMPLANT. IT WAS INDICATED, THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013 AT A CLINIC "TO SEE IF THERE WAS ANYTHING DIFFERENT THAT THEY COULD DO." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26149	SOLETRA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	7426

Patients

Seq	Age	Sex	Outcome	Treatment
1