MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problem Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

It was reported that the implantable neurostimulator (ins) was turned off.It was noticed that it was off while recharging the implant.It was noted that the patient¿s walking had been bad for the past 2 weeks prior to the date of this report.The patient was struggling to walk.The healthcare professional indicated that if this continued the patient would lose the ability to walk.The patient programmer and the desktop charger were lost.It was noted that the patient had received a replacement patient programmer in the past.Patient¿s status was unknown.It was later reported that stimulation was turning off on its own.Patient had a security system at school and the healthcare professional (hcp) thought this was what was doing it.The patient¿s stimulation had been off for 3-4 weeks prior to the date of this report.The patient¿s gait had been off since (b)(6) 2013 and seemed to continue to get worse.The patient was walking on the inside of the left foot, which was affecting her hip.Patient may need to have another lead or possible new implantable neurostimulator (ins).It was noted that they thought the patient¿s gait was off because the system was off.Patient¿s previous inss were replaced due to normal battery depletion.It was noted that they were not rechargeable and had to be replaced after 10 months.Patient¿s current ins was rechargeable.It was noted that the hcp stated that if she did not get this fixed she would end up ¿loosing it.¿ patient needed assistance turning stimulation back on with the recharger.It was noted that the lightning bolt would not appear on the screen.The patient programmer was found and they were able to turn stimulation back on.The programmer was showing on and ok at 4.50 on the left side and 4.00 on the right side.The patient was on b.Additional information received reported the cause of the event was the patient¿s ins turned off by itself and a new patient programmer was requested.The event was attributed to the programmer.It was noted that it was omitted reporting she lost it and tried to use malfunction report to get a new patient programmer.Patient¿s mother was unable to check the battery charge because she lost it.It was noted they had not tried reading the charge with the charging unit.The hcp had not seen the patient.No surgical intervention had occurred.It was noted that this was the second time the patient¿s mother lost the patient programmer.No hospitalization was required as a result of the event.There was no patient injury.Hcp was unaware of patient¿s current condition.

Manufacturer Narrative

Concomitant medical products: product id: 37752, serial# (b)(4), product type: recharger.Product id: 37085-40, serial# (b)(4) implanted: (b)(6) 2009, product type: extension.Product id: 3387s-40, lot# v132495, implanted: (b)(6) 2009, product type: lead.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37642, serial# (b)(4), implanted: (b)(6) 2009, product type: programmer, patient.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 7426, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 3774095
• MDR Text Key: 20265219
• Report Number: 3004209178-2014-08131
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2010
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2014
• Date Device Manufactured: 11/21/2009
• 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 Age: 00013 YR