MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Dysphasia (2195); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_adaptor_acc, lot# unknown, product type: accessory.Other relevant device(s) are: product id: neu_adaptor_acc, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for parkinson's disease.The patient's life was allegedly ruined by a faulty device.Two hours after ins replacement, in which an adapter was also implanted, the patient began to have big problems: difficulty in movement and speech and shocks all over their body.The impedance was reportedly very high, but, per the consumer, according to technicians there were no problems despite the patient being very ill.The patient was re-operated after six terrible months where the physicians realized the battery had been "screwed up incorrectly" and the physicians remedied the previous errors.The patient was still in worse condition.The new ins, due to the adapter, was very cumbersome.The patient had continuous pains, posture problems, considerable difficulty to remain lying in bed.At night, the patient was forced to sleep on the sofa due to strong spasms on the shoulder that the device allegedly caused.No further complications were reported.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8248162
• MDR Text Key: 133068700
• Report Number: 3007566237-2019-00153
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR