MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported that in (b)(6) 2009 the patient experienced ¿sudden internal capsule stimulation symptoms and visual symptoms in the left upper limb.¿ it was noted these stimulation conditions were ¿the same as the ones before.¿ it was stated that in (b)(6) 2009 ¿impedance abnormalities in the right electrode¿ were discovered.It was further stated the patient¿s therapeutic impedance at that time was 826 ohms compared to 1342 ohms when measured on (b)(6) 2008.It was reported the patient¿s stimulation was reduced on (b)(6) 2009 ¿so that stimulation symptoms would not occur.¿ it was stated that the patient¿s resistance and current fluctuated every time a measurement was taken and that ¿they were unstable.¿ it was further stated that when the resistance was checked again on (b)(6) 2009 ¿it was still unstable.¿ when checked in (b)(6) 2009, it was reported that the patient¿s right electrodes 0 and 3 had ¿low¿ resistances.The impedance testing results from (b)(6) 2009 indicated the ¿low¿ impedances that were measured on the right electrodes #0 and #3 at 3 volts were 582 ohms and 636 ohms respectively.It was reported the patient¿s batteries were replaced due to ¿low residual quantity.¿ a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type lead; product id neu_unknown_ext, serial# unknown, product type extension.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 3855295
• MDR Text Key: 4680522
• Report Number: 3007566237-2014-01563
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• 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: 05/09/2014

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: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/09/2014
• 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