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

Model Number 37601

Device Problem Premature Discharge of Battery (1057)

Patient Problems Skin Irritation (2076); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient was not doing well, could not have anything touch his skin, could not eat and could not sleep.The patient¿s implantable neurostimulator (ins) was replaced on (b)(6) 2014.The ins had died about 2 months prior to the date of this report which was the same that the patient not being able to have anything touch his skin had started.The ins had only been in about 3.5 years and the patient had been under the assumption that it would be about 6 years.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v648226, implanted: (b)(6) 2011, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(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: 4230542
• MDR Text Key: 16560217
• Report Number: 3004209178-2014-21029
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2014
• Date Device Manufactured: 12/14/2010
• 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: 00059 YR