FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 4893054 · Received July 6, 2015

Report

Report Number: 3007566237-2015-01883
Event Type: Malfunction
Date Received: July 6, 2015
Date of Event: June 15, 2015
Report Date: October 3, 2018
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION. PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4)

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE REPORTED THE PATIENT WAS DOING WELL. THE PATIENT'S HEALTH CARE PROVIDER WAS ABLE TO PROGRAM AROUND THE ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS A STAGE 2 PROCEDURE ON THE DAY OF REPORT AND THE LEAD LOCATION WAS AT THE GLOBAL PALLIDUS INTERNA (GPI). THE EXTENSION AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WERE IMPLANTED BUT POST-IMPLANT THE IMPEDANCES WERE CHECKED AND A SHORT WAS NOTED. IMPEDANCES WERE: C<(>&<)>8 2443, C<(>&<)>9 1078, C<(>&<)>10 1784, C <(>&<)>11 1084, 9<(>&<)>11 102. THE PATIENT HADN¿T BEEN PROGRAMMED YET.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
435037	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1