MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Break (1069); Difficult to Remove (1528); Low impedance (2285)

Patient Problems Foreign Body Reaction (1868); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that the there was a possible short circuit.The physician interrogated the implantable neurostimulator (ins) after the patient reported a loss of therapy, less than 50% therapy relief at the device pocket.Impedance testing was performed.Interrogation revealed very low impedances on one side, specific values and electrodes with issue were not specified.The patient reported no event that could explain external damage to the extension or ins.The patient was hospitalized.The patient also experienced tingling sensation around the ins pocket area.The patient underwent a revision that revealed a broken extension.The extension was removed and replaced with a new one.The ins and lead remained fine in use.The case was closed.The company representative confirmed the system had been implanted for three months only.The rep could only speculate and has no real idea how this could have happened.The neurosurgeon thinks the patient have a very active immune system that attacked the extension from the very first day.The extension was very hard to extract as there was tissue grown all over the cable.The patient did not have any recent surgical intervention in the extension area.The patient was fine again after the extensions were replaced.Therapy works fine also.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id: neu_unknown_ext, product type: extension.(b)(4).

• Brand Name: ACTIVA
• 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: 4929046
• MDR Text Key: 6015244
• Report Number: 3007566237-2015-02036
• 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: Physician
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/21/2015
• 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