MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that on the date of this report during an intra-operative troubleshooting they were using an external neurostimulator (ens) and twistlock to troubleshoot on the lead directly.When they had tested at 3.0v, open circuit values on all of the 0 contacts and 1/3 and 2/3 were seen.Prior to the procedure the patient had a short on electrodes 2 and 3, 32 ohms.They disconnected and reseated the lead in the twistlock and it was noted that they were using the short stylet knob.Impedances were retested at 3.0v following reconnecting and no values were out of range.They disconnected and had indicated they would replace the extension.The extension and the battery were replaced on the left side.All impedances were back in range and the patient was doing fine post-operatively.Patient therapy had resumed.

Manufacturer Narrative

Concomitant products: product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 7482a51, serial # (b)(4), product type extension; product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 3387s-40, lot # v818201, product type lead; product id 37085-60, serial # (b)(4), product type extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4409316
• MDR Text Key: 19607294
• Report Number: 3004209178-2015-00540
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2014
• Date Device Manufactured: 09/05/2013
• 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: 00085 YR