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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported the essential tremor patient experienced a sudden loss of stimulation and therapeutic effect and a ¿shocking/jolting sensation.¿ the patient also experienced a burning sensation, pain, and less than 50% therapy relief on half of their body.The patient¿s lead had reportedly experienced a fracture above the connector and was scheduled to be replaced as a result.The patient was hospitalized as a result of the event.It was noted the patient had not experienced any traumas prior to the event.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, serial# unknown, product type: lead.(b)(4).

Manufacturer Narrative

Product id: 3387-40, serial# unknown, explanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

Additional information reported that during the scheduled replacement "the lead had been cut several times instead of being dissected" and that the operating surgeon "also just took the cranial part out and left the rest in." it was notably not planned to return the device for analysis.

• 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 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4259519
• MDR Text Key: 17630549
• Report Number: 3007566237-2014-03380
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• 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): Hospitalization; Required Intervention